Trial Outcomes & Findings for Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer (NCT NCT01565499)

Last Updated: 2023-03-30

Results Overview

The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

After surgery, up to 4 months

Results posted on

2023-03-30

Participant Flow

There are two patients that have not received any cycle and they are excluded of analysis by ITT criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Overall Study STARTED	83
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-Paclitaxel The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Overall Study Physician Decision	1
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Age, Continuous	47 years n=99 Participants
Sex: Female, Male Female	81 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	79 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=99 Participants
Menopausal Status Premenopausal	52 Participants n=99 Participants
Menopausal Status Postmenopausal	29 Participants n=99 Participants
Hormonal status Estrogen Receptor (ER) (+) and Progesterone R (+)	62 Participants n=99 Participants
Hormonal status ER (+) and Progesterone R (-)	17 Participants n=99 Participants
Hormonal status ER (+) and Progesterone R (Not available)	2 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 0	79 Participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 1	2 Participants n=99 Participants
Clinical Tumor size T1	9 Participants n=99 Participants
Clinical Tumor size T1c	8 Participants n=99 Participants
Clinical Tumor size T2	42 Participants n=99 Participants
Clinical Tumor size T3	18 Participants n=99 Participants
Clinical Tumor size T4a	1 Participants n=99 Participants
Clinical Tumor size T4b	3 Participants n=99 Participants
Clinical Nodal status N0	30 Participants n=99 Participants
Clinical Nodal status N1	43 Participants n=99 Participants
Clinical Nodal status N2	5 Participants n=99 Participants
Clinical Nodal status NX	3 Participants n=99 Participants
Clinical Stage Stage I	4 Participants n=99 Participants
Clinical Stage Stage II	56 Participants n=99 Participants
Clinical Stage Stage III	18 Participants n=99 Participants
Clinical Stage Unknown	3 Participants n=99 Participants
Histopathologic Grade Grade 1	9 Participants n=99 Participants
Histopathologic Grade Grade 2	39 Participants n=99 Participants
Histopathologic Grade Grade 3	26 Participants n=99 Participants
Histopathologic Grade Unknown	7 Participants n=99 Participants
Breast Surgery Planned Mastectomy	50 Participants n=99 Participants
Breast Surgery Planned Quadrantectomy	17 Participants n=99 Participants
Breast Surgery Planned Lumpectomy	10 Participants n=99 Participants
Breast Surgery Planned Not available	4 Participants n=99 Participants

PRIMARY outcome

Timeframe: After surgery, up to 4 months

Population: From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment. Unknown: The RCB evaluation was available for 80 of the 81 treated patients (one patient received three cycles but refused further treatment and withdrew the informed consent).

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
The Residual Cancer Burden Grade III (RCB-III). RCB III: Extensive residual disease (>3.28)	23 Participants
The Residual Cancer Burden Grade III (RCB-III). RCB II: Moderate residual disease (1.36-3.28)	37 Participants
The Residual Cancer Burden Grade III (RCB-III). RCB I: Minimal residual disease (>0-1.36)	14 Participants
The Residual Cancer Burden Grade III (RCB-III). RCB 0: No residual disease (0)	6 Participants
The Residual Cancer Burden Grade III (RCB-III). Unknown	1 Participants

SECONDARY outcome

Timeframe: After surgery, up to 4 months

Objective Response was measured following the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. For the purpose of this study a response is defined as the achievement of a complete or partial response measured by breast MRI. Pathological complete response (pCR) was evaluated following the Symmans method at the time of the definitive surgery. For the purpose of this study RCB-0 was considered a pCR. The pCR (RCB-0) rate (pCRR) was reported including a 95% confidence interval. The estimate of the pCR rate was calculated as follows by central laboratory: pCR Rate = Number of patients with pCR / ITT population.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Pathologic Complete Response (pCR) Rate	6 Participants

SECONDARY outcome

Timeframe: After surgery, up to 4 months

The ORR was reported including a 95% confidence interval. The estimate of the ORR was determined according to RECIST 1.1 and measured by MRI and mammogram in patients treated with this regimen. ORR was calculated as follows: Overall Response Rate = Number of Complete Responses (CRs), Partial Responses (PRs) / ITT population

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)	62 Participants

SECONDARY outcome

Timeframe: After surgery, up to 4 months

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Objective Response Rate (ORR) by Mammogram	49 Participants

SECONDARY outcome

Timeframe: Up to 6 years

IDFS was defined as the time (days) from the date of randomization until the date of objective recurrent disease (local, regional or distant), second primary invasive malignancy (breast or non-breast) or death from any cause. For patients not known to have died as of the data cut-off date and who do not have recurrent disease or second primary tumor, invasive disease-free survival will be censored at the last contact date. Ductal carcinoma in-situ (DCIS) will not be considered an event for the purpose of this analysis.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Invasive Disease Free Survival (IDFS)	4.89 years Standard Deviation 1.10

SECONDARY outcome

Timeframe: After surgery, up to 4 months

Population: From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment. Mastectomy was de initial planned surgery for 50 patients.

The conversion from the initially planned mastectomy to BCS was reported including a 95% confidence interval. The estimate of the rate of conversion to BCS was calculated as follows: BCS rate = Number of patients with BCS / Number of patients with initially planned mastectomy.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=50 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Rate of Conversion to Breast Conserving Surgery (BCS) Breast-conserving surgery	20 Participants
Rate of Conversion to Breast Conserving Surgery (BCS) No Breast-conserving surgery	30 Participants

SECONDARY outcome

Timeframe: During treatment and until 30 days after the last dose of each patient study treatment

Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010) that occur during the study treatment period or within 30 days of the last dose of study treatment, regardless of causality and according to the relationship to study drug as assessed by the investigator, were collected and evaluated.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=81 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
The Number of Participants Who Experienced Adverse Events (AE)	81 Participants

SECONDARY outcome

Timeframe: Baseline visit

Population: Of the 81 patients, 77 had available pretreatment tumors for biomarker central analysis. Of these 77, 5 were excluded (3 due to Triple Negative (TN) phenotype, 1 due to missing pathological response data, and 1 due to incomplete central biomarker data). Ki67 was determined in 72 tumors and correlated to RCB (DOI: 10.1634/theoncologist.2017-0052)

Ki67 was analysed by immunohistochemistry following the American Society of Clinical Oncology and the College of American Pathologists guidelines. The cut-off considered for Ki67 expression was 20% of positively stained tumor cells.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=72 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response ≥ 20 %	40 Participants
Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response < 20 %	32 Participants

SECONDARY outcome

Timeframe: Baseline visit

Population: 83 patients registered, but 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium. Of the 81 patients, 77 had available pretreatment tumors for biomarker central analysis. Of these 77, 5 were excluded (3 due to Triple Negative (TN) phenotype, 1 due to missing pathological response data, and 1 due to incomplete central biomarker data). Cav-1 was determined in 72 tumors and correlated to RCB (DOI: 10.1634/theoncologist.2017-0052)

Caveolin (Cav)-1 was evaluated in the stroma and its expression was categorized in low, moderate, or high (tertile). The high expression of Cav-1 was considered as positive.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=72 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response Positive	19 Participants
Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response Negative	53 Participants

SECONDARY outcome

Timeframe: Baseline visit

Population: 83 patients registered, but 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium. Of the 81 patients, 77 had available pretreatment tumors for biomarker central analysis. Of these 77, 5 were excluded (3 due to Triple Negative (TN) phenotype, 1 due to missing pathological response data, and 1 due to incomplete central biomarker data). SPARC was determined in 72 tumors and correlated to RCB (DOI: 10.1634/theoncologist.2017-0052)

SPARC was evaluated for both tumor and stroma. Its expression was categorized as negative when the intensity was absent-to-weak (1), or moderate (11)-to-strong (111) with a proportion of stained cells \<10%. Immunolabeling was positive if the intensity was moderate (11)-to-strong (111) and the extent of staining was 10%.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=72 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response SPARC stroma · Positive	65 Participants
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response SPARC stroma · Negative	7 Participants
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response SPARC tumor · Positive	7 Participants
Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response SPARC tumor · Negative	65 Participants

SECONDARY outcome

Timeframe: Baseline

Population: 83 patients registered, but 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium. Of the 81 patients, 77 had available pretreatment tumors for biomarker central analysis. Of these 77, 5 were excluded (3 due to TN phenotype, 1 due to missing pathological response data, and 1 due to incomplete central biomarker data). Molecular subtypes was determined in 72 tumors and correlated to RCB (DOI: 10.1634/theoncologist.2017-0052)

Molecular subtypes were classified according to St. Gallen criteria 2013 and Prat et al. into Luminal A (ER+, Progesterone Receptor (PgR) \>20%, Human Epidermal growth factor Receptor 2 - (HER2), Ki67 \<14%), Luminal B1 (ER+, HER2-, PgR \>20% and/or Ki67 \<14%), Luminal B2 (ER+, HER2+, any PgR, any Ki67), TN (ER-, PgR-, HER2-), and HER2-enriched (ER-, PgR-, HER2+) subtypes.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=72 Participants The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response Luminal B1	53 Participants
Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response Luminal A	19 Participants

Adverse Events

Nab-Paclitaxel

Serious events: 6 serious events

Other events: 81 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Nab-Paclitaxel n=81 participants at risk The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Respiratory, thoracic and mediastinal disorders Community-acquired pneumonia	1.2% 1/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Gastrointestinal disorders Colitis	1.2% 1/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Nervous system disorders Multiple Sclerosis Relapse	1.2% 1/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Skin and subcutaneous tissue disorders Local Infection Reservoir Area	1.2% 1/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Nervous system disorders Neurotoxicity	2.5% 2/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.

Other adverse events

Other adverse events
Measure	Nab-Paclitaxel n=81 participants at risk The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. Nab-paclitaxel
Investigations Neutrophil Count Decreased	25.9% 21/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Investigations Neutrophil count decreased	27.2% 22/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Vascular disorders Hypertension	7.4% 6/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Skin and subcutaneous tissue disorders Alopecia	14.8% 12/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 7/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
General disorders Fatigue	48.1% 39/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Reproductive system and breast disorders Irregular Menstruation	4.9% 4/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Musculoskeletal and connective tissue disorders Myalgia	18.5% 15/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Nervous system disorders Peripheral Sensory Neuropathy	2.5% 2/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Infections and infestations Upper Respiratory Infection	4.9% 4/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Investigations White Blood Cell Decreased	35.8% 29/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Investigations Alanine Aminotransferase Increased	37.0% 30/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Investigations Aspartate Aminotransferase Increased	16.0% 13/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Blood and lymphatic system disorders Anemia	71.6% 58/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Gastrointestinal disorders Diarrhea	28.4% 23/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Metabolism and nutrition disorders Hyperglycemia	21.0% 17/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Gastrointestinal disorders Mucositis Oral	16.0% 13/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Gastrointestinal disorders Nausea	28.4% 23/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
Skin and subcutaneous tissue disorders Nail Changes	14.8% 12/81 • All AEs occurring during the study and until the treatment discontinuation visit 30 days after the last study medication, an average of 4 months per participant From the 83 patients registered, there were 2 patients that had not received any cycle and they were excluded of analysis by Intent To Treat (ITT) criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60