A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without an Active Drug in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

Brief summary

The study seeks to evaluate the efficacy and tolerability of an active drug/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

Interventional study

Metastatic Breast Cancer
509 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Double (Participant, Investigator)


Eligibility criteria

Participant attributes:
Male and Female


18 Years and older.

Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer that is either locally
advanced or metastatic. Locally advanced breast cancer must not be amenable to
surgical resection or radiation with curative intent.

2. Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer
Gene 2 (BRCA2) germline mutation.

3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.

4. Measurable or non-measurable (but radiologically evaluable) disease per Response
Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT)
scan (within 28 days of randomization) with at least one lesion outside previously
irradiated areas.

5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.

6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).

Exclusion Criteria:

1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin,
capecitabine) for metastatic disease.

- Regimens received in the adjuvant/neoadjuvant setting or for locally advanced
breast cancer within the past 6 months will also be considered toward the maximum
of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer
event will count as one prior line of therapy, if received within the past 6

- Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and
signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab)
are allowed and are not counted towards the prior line of therapy.

2. Progressed or recurred within 12 months of completing platinum therapy or received > 1
prior line of platinum therapy for breast cancer in any setting (adjuvant,
neoadjuvant, or metastatic).

3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.

4. Prior taxane therapy administered for the treatment of metastatic breast cancer with
the below exceptions.

- Prior taxane therapy for metastatic breast cancer is allowed if the patient
received ≤ 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects
receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for
subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of
progression or if taxane therapy for metastatic disease was > 12 months prior to
Cycle 1 Day-2 (C1D-2).

- Use of taxanes as adjuvant therapy or to treat locally advanced disease is
permitted, if given more than 6 months prior to C1D-2

5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant
Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also
known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

6. Active CNS metastases or leptomeningeal disease.

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