Trial Outcomes & Findings for Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer (NCT NCT00194792)

NCT ID: NCT00194792

Last Updated: 2017-07-11

Results Overview

Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

1 month

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Hormone Therapy and Chemotherapy) See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study STARTED	28
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Hormone Therapy and Chemotherapy) See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Hormone Therapy and Chemotherapy) n=28 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Age, Continuous	55 years n=99 Participants
Sex: Female, Male Female	28 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	26 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 month

Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Number of Participants With Clinical Response	19 Participants

PRIMARY outcome

Timeframe: From date of treatment start to surgery

Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response	0 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Kaplan-Meier estimate assessed at 5 years

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Disease-free Survival	0.76 disease free survival probability Interval 0.61 to 0.95

PRIMARY outcome

Timeframe: Up to 5 years

From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Overall Survival	0.88 survival probability Interval 0.76 to 1.0

PRIMARY outcome

Timeframe: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)

Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities Grade 2	80 events
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities Grade 3	12 events
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities Grade 4	0 events
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities Fatal toxicity	0 events

PRIMARY outcome

Timeframe: During adjuvant and neoadjuvant chemotherapy

Count of patients with dose reduction, treatment interruption, or treatment discontinuation.

Outcome measures

Outcome measures
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 Participants See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation Adjuvant therapy	1 Participants
Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation Neoadjuvant therapy	11 Participants

SECONDARY outcome

Timeframe: Weekly during CHB and XMN and pacitaxel

Population: Molecular marker data was not collected for this cohort and thus not possible to report results for this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Hormone Therapy and Chemotherapy)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Hormone Therapy and Chemotherapy) n=27 participants at risk See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Vascular disorders High Blood Pressure	7.4% 2/27
General disorders Fatigue	63.0% 17/27
Gastrointestinal disorders Nausea	59.3% 16/27
Gastrointestinal disorders Dysgeusia	14.8% 4/27
General disorders Fever	14.8% 4/27
Investigations SGOT Increased	33.3% 9/27
Investigations SGPT Increased	37.0% 10/27
Investigations Albumin Decreased	18.5% 5/27
Investigations Potassium Decreased	25.9% 7/27
Psychiatric disorders Anxiety	14.8% 4/27
Gastrointestinal disorders Diarrhea	25.9% 7/27
Skin and subcutaneous tissue disorders Alopecia	11.1% 3/27
Gastrointestinal disorders Mucositis (GI)	7.4% 2/27
Gastrointestinal disorders Mucositis (Oral)	22.2% 6/27
Investigations Neutrophil Count Decreased	51.9% 14/27
Investigations Alkaline Phosphatase Increased	22.2% 6/27
Respiratory, thoracic and mediastinal disorders Dyspnea	7.4% 2/27
Psychiatric disorders Insomnia	22.2% 6/27
Gastrointestinal disorders Heartburn	7.4% 2/27
Investigations Hemoglobin Decreased	59.3% 16/27
Investigations White Blood Cells Decreased	66.7% 18/27
Psychiatric disorders Depression	25.9% 7/27
General disorders Pain (arm)	7.4% 2/27
Vascular disorders Hot Flashes/Night Sweats	51.9% 14/27
General disorders Pain (neck & jaw)	7.4% 2/27
General disorders Pain (back)	14.8% 4/27
Gastrointestinal disorders Constipation	18.5% 5/27
Nervous system disorders Headache	14.8% 4/27
General disorders Pain (subcostal)	11.1% 3/27
Gastrointestinal disorders Pain (abdominal)	11.1% 3/27
Skin and subcutaneous tissue disorders Dry Skin (hands)	7.4% 2/27
Investigations Hematocrit Decreased	7.4% 2/27
Investigations Hypocalcemia	11.1% 3/27
General disorders Joint Pain/Muscle Aches	18.5% 5/27
Reproductive system and breast disorders Amenorrhea	7.4% 2/27
Gastrointestinal disorders GI Upset/Reflux	7.4% 2/27
Investigations Sodium Decreased	11.1% 3/27
Skin and subcutaneous tissue disorders Hand Foot Syndrome	14.8% 4/27
Respiratory, thoracic and mediastinal disorders Common Cold	14.8% 4/27
Gastrointestinal disorders Vomiting	7.4% 2/27
Skin and subcutaneous tissue disorders Rash (Eczema)	7.4% 2/27
Investigations Lactate Dehydrogenase Increased	25.9% 7/27
Investigations Glucose Increased	11.1% 3/27
Musculoskeletal and connective tissue disorders Pain (bone)	11.1% 3/27
Reproductive system and breast disorders Yeast Infection (vaginal)	7.4% 2/27
Skin and subcutaneous tissue disorders Dry Skin	14.8% 4/27
Respiratory, thoracic and mediastinal disorders SOB with activity	11.1% 3/27
Renal and urinary disorders UTI	11.1% 3/27
Skin and subcutaneous tissue disorders Hyperpigmentation (lymphs)	7.4% 2/27

Additional Information

Dr. Hannah Linden

University of Washington / Seattle Cancer Care Alliance

Phone: 206-288-6989

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place