Trial Outcomes & Findings for Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer (NCT NCT00256243)

Results Overview

Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

5 years

Results posted on

2018-03-02

Participant Flow

Subjects recruited At University of California Irvine Medical Center (UCIMC) are recruited by referral for UCIMC inpatients or outpatients.

Participant milestones

Participant milestones
Measure	Chemotherapy With GM-CSF Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Overall Study STARTED	48
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy With GM-CSF Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Overall Study Lost to Follow-up	2
Overall Study Death	7
Overall Study Not treated	1

Baseline Characteristics

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy With GM-CSF n=48 Participants Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	50.29 years STANDARD_DEVIATION 11.08 • n=99 Participants
Sex: Female, Male Female	48 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.

Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.

Outcome measures

Outcome measures
Measure	Chemotherapy With GM-CSF n=47 Participants Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Clinical Response Rate	47 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.

pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.

Outcome measures

Outcome measures
Measure	Chemotherapy With GM-CSF n=47 Participants Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Microscopic Pathological Response Rate	47 Participants

Adverse Events

Chemotherapy With GM-CSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rita Mehta

Chao Family Comprehensive Cancer Center

Phone: (714) 456-5153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place