A Study Evaluating Safety and Efficacy of the Addition of an Active Drug Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Brief summary

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of an active drug plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Interventional study

Triple Negative Breast Cancer
634 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Eligibility criteria

Participant attributes:


From 18 Years to 99 Years.

Inclusion Criteria:

1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy
(excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical
exam or radiologic studies.

2. Documented Breast Cancer Gene (BRCA) germline mutation testing.

3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth
Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.

4. ECOG Performance status of 0 to 1.

5. Women must be determined to be not of childbearing potential (surgically sterile, or
postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR
they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic
therapy radiotherapy or investigational agents) with therapeutic intent for current
breast cancer.

2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a
Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal
agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator
(SERM). Subjects must have discontinued use of such agents prior to beginning study

4. A history of seizure within 12 months prior to study entry.

5. Pre-existing neuropathy from any cause in excess of Grade 1.

All the cities where the clinical studies are located

Toronto - M4N 3M5
Montreal - H3T 1E2
Montréal - H2X 0A9
Quebec City - G1S 4L8
Quebec City - G1S 4L8

More information about this study