Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer

  • STATUS
    Not Recruiting
  • participants needed
    25
  • sponsor
    University of Illinois at Chicago
Updated on 28 May 2022
platelet count
paclitaxel
cancer
cyclophosphamide
estrogen
carcinoma
breast cancer
growth factor
gilbert's syndrome
progesterone
doxorubicin
metastasis
neutrophil count
carboplatin
immunohistochemistry
epidermal growth factor receptor
HER2
EGFR
triple negative breast cancer
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
breast carcinoma
invasive breast cancer
mastectomy
lumpectomy
core needle biopsy
sentinel lymph node biopsy
excisional biopsy
carboplatin/paclitaxel

Summary

Nonrandomized, open label, single arm, Simon's two stage MinMax design trial of neoadjuvant weekly carboplatin plus paclitaxel, followed by doxorubicin and cyclophosphamide in patients with operable Triple Negative Breast Cancer (TNBC)

Description

This is a single arm, Phase 2, open label, Simon's two stage MinMax design trial to evaluate the safety and efficacy of weekly carboplatin in combination with standard neoadjuvant chemotherapy in subjects with previously untreated triple negative breast cancers who are candidates for potentially curative surgery.

Subjects will receive carboplatin (Area Under the Curve (AUC) 2 mg/mL/min) + paclitaxel (80 mg/m2) Carboplantin plus Paclitaxel (CbP) followed by doxorubicin and cyclophosphamide (AC). All subjects will receive CbP on Day 1 of 12 weekly cycles (Visits CbP1 - CbP12) via infusion during Chemotherapy Segment 1 as indicated in the Study Schema. Dose interruptions and dose modifications are allowed based upon tolerability and may extend Chemotherapy Segment 1 duration to a maximum of 16 weeks. Beginning with Chemotherapy Segment 2 all subjects will receive doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) on Day 1 of four 14-day cycles (Visits AC1 - AC4). For subjects who experience toxicities due to carboplatin, paclitaxel, doxorubicin or cyclophosphamide, the appropriate dose modifications or dosing delays should be managed according to Section 11.2. Dose modifications may result in the total duration of therapy being greater than the planned 24 weeks. The objective of this study is to determine efficacy and tolerability of low dose, weekly carboplatin in combination with weekly paclitaxel followed by standard doxorubicin/cyclophosphamide as neoadjuvant therapy for triple-negative breast cancer.

Details
Condition Triple Negative Breast Cancer
Treatment cyclophosphamide, carboplatin, Paclitaxel, doxorubicin
Clinical Study IdentifierNCT04083963
SponsorUniversity of Illinois at Chicago
Last Modified on28 May 2022

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