A Phase 3 interventional study of Abraxane and Paclitaxel in Breast Cancer, sponsored by Fondazione Michelangelo. Completed at 67 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Fondazione Michelangelo · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery.
In this study, eligible and consenting patients will be randomized to receive either 4 cycles of weekly abraxane (nab-paclitaxel) followed by 4 cycles of an anthracycline-containing regimen or 4 cycles of weekly paclitaxel followed by 4 cycles of an anthracycline-containing regimen.The anthracycline regimen (AC, EC or FEC) will be chosen by the investigator at the participating sites.
Before randomization patients will be stratified according to Disease stage [operable (tumor stage: T2N0-1; T3N0) and locally advanced (T3N1;T4, any N2-3)] and Tumor subtype [luminal B intermediate (HER2 negative, ER or PGR positive, Ki67 from 14% to 20%) vs luminal B high (HER2 negative, ER or PGR positive, Ki67 >20%) vs triple negative tumors (HER2 negative, ER negative and PgR negative, Ki67 any value)]. Tumor subtype will be confirmed at two selected referral laboratories.
Neoadjuvant chemotherapy will be followed by definite surgery and irradiation as per international and local guidelines.
During neoadjuvant chemotherapy patients will be assessed for safety and efficacy as detailed in the protocol.
After definite surgery patients will be followed for approximately 10 years according to local procedures
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 632 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione Michelangelo is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Paclitaxel will be given on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles. AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles
Drug: Paclitaxel
Abraxane will be given at the dosage of 125 mg/m2 on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles. AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles
Drug: Abraxane
Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
Also known as: Nab-paclitaxel
Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
Also known as: No specific brand name
pathologic Complete Response (pCR)
To compare the rate of pathologic Complete Response (pCR, absence of invasive disease in breast and nodes (ypT0/ypTis, ypN0)) for abraxane (Abraxane®, abraxane) vs paclitaxel.
Time frame: At the time of surgery: 40 months after the randomization of the first patient
clinical Overall Response (cOR)
To compare the rate of clinical overall response (cOR) after the first 4 cycles of abraxane vs paclitaxel and to compare the rate of cOR after the entire preoperative chemotherapy (i.e. before surgery) in the study arms of abraxane vs paclitaxel
Time frame: At the time of surgery: 40 months after the randomization of the first patient
Event Free Survival (EFS)
To compare the Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) in the study arms of abraxane vs paclitaxel
Time frame: 5 years after the first patient in and 10 years after randomization of last patient in
Distant Event Free Survival (DEFS)
The distant event free survival (DEFS) is defined as the time from randomization to the first date of distant metastasis while on primary therapy or distant recurrence after surgery or death due to any cause. Patients who terminate the study without evidence of any of the above events will be censored at the date of their last follow-up tumor assessment
Time frame: 5 years after the first patient in and 10 years after randomization of last patient in
Local Event Free Survival
The local event free survival (LEFS) is defined as the time from randomization to the first date of local progression while on primary therapy or local recurrence after surgery. Rules for censoring and methods of analysis will be the same as defined for EFS
Time frame: 5 years after the first patient in and 10 years after randomization of last patient in
Regional Event Free Survival
The regional event free survival (REFS) is defined as the time from randomization to the first date of regional progression while on primary therapy or regional recurrence after surgery. Rules for censoring and methods of analysis will be the same as defined for EFS.
Time frame: 5 years after the first patient in and 10 years after randomization of last patient in
Overall Survival (OS)
The overall survival (OS) is defined as the time from randomization to the date of death. Patients alive at the end of study will be censored at their last contact date.
Time frame: 13 years from the date of first patient in
Safety and Tolerability
Patients will be assessed for adverse events by clinical examination, questioning for symptoms of toxicity, laboratory assessments, vital signs, ECG and LVEF. Neurological toxicity and other toxicities will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0.
Time frame: Each participant will be followed for the duration of treatment period, approximately 9 months
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Fondazione Michelangelo