Trial Outcomes & Findings for Neoadjuvant Treatment of Breast Cancer (NCT NCT00254592)

Results Overview

Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

3 years

Results posted on

2019-02-28

Participant Flow

Subjects were recruited at UCIMC by the following methods: referral for University of California Irvine Medical Center (UCIMC) inpatients or outpatients.

Participant milestones

Participant milestones
Measure	Chemotherapy With GM-CSF Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Overall Study STARTED	43
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Treatment of Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy With GM-CSF n=43 Participants Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=99 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants
Age, Continuous	52 years STANDARD_DEVIATION 12.8 • n=99 Participants
Sex: Female, Male Female	43 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	43 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 years

Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).

Outcome measures

Outcome measures
Measure	Chemotherapy With GM-CSF n=43 Participants Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Overall Clinical Response to the Dose Dense Regimen	43 Participants

Adverse Events

Chemotherapy With GM-CSF

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy With GM-CSF n=43 participants at risk Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Immune system disorders Neutropenic fever	7.0% 3/43 • Number of events 3
Cardiac disorders Cardio Vascular Disease	2.3% 1/43 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Rita S. MEHTA, MD

University of California Irvine Medical Center

Phone: (714) 456-5153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place