NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to evaluate the usual and the reverse sequence of an anthracycline followed by a taxane in locally advanced breast cancer.

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Detailed Description

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Anthracylines and taxanes are the most active chemotherapy agents in the treatment of breast cancer. The usual sequence of an anthracycline followed by a taxane is due to the timing of their discovery and introduction in the treatment armamentarium. More recent evidence suggests that there is pre clinical as well as clinical rational for the reverse sequence.

The neoadjuvant approach allows quick evaluation of these different treatment strategies. At the same time, the study will collect tissue biopsies and blood at different time points in order to evaluate predictive biomarkers.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FAC x 3 followed by Docetaxel x 3

Group Type ACTIVE_COMPARATOR

FAC x 3 followed by Docetaxel x 3

Intervention Type DRUG

5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles; followed by Docetaxel 100 mg/m2 every 21 days, for 3 cycles

Docetaxel x 3 followed by FAC x 3

Group Type EXPERIMENTAL

Docetaxel x 3 followed by FAC x 3

Intervention Type DRUG

Docetaxel 100 mg/m2 IV every 21 days, for 3 cycles; followed by 5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles

Interventions

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FAC x 3 followed by Docetaxel x 3

5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles; followed by Docetaxel 100 mg/m2 every 21 days, for 3 cycles

Intervention Type DRUG

Docetaxel x 3 followed by FAC x 3

Docetaxel 100 mg/m2 IV every 21 days, for 3 cycles; followed by 5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Stage IIB to IIIB HER-2 negative breast cancer
2. ECOG performance status ≤ 2
3. Neuropathy grade \<1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)
4. Adequate hematologic function with:

* Absolute neutrophil count (ANC) \>1500/μL
* Platelets ≥100,000/μL
* Hemoglobin ≥ 9 g/dL
5. Adequate hepatic and renal function with:

* Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x institutional ULN
* Alkaline phosphatase ≤2.5 x institutional ULN
* Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min
6. Adequate cardiac function

* Left ventricular ejection fraction (LVEF) within institutional normal range
7. Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria

1. Pregnancy
2. Bilateral, synchronous breast cancer
3. Previous diagnosis of breast or other cancer
4. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that would make the patient inappropriate for this study

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No