The Study Evaluating Efficacy And Tolerability Of an Active Drug in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer

Brief summary

The Study Evaluating Efficacy And Tolerability of an active drug in Combination with Temozolomide or an active drug/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Interventional study

Metastatic Breast Cancer
294 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:

- Histologically or cytologically confirmed breast cancer that is either locally
recurrent or metastatic.

- Locally recurrent disease must not be amenable to surgical resection or radiation with
curative intent.

- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline

- If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received
and progressed on at least one prior standard HER2 directed therapy or the subject
must be ineligible to receive anti-HER2 therapy.

- Measurable or non-measurable (but radiologically evaluable) disease by RECIST
(Response Evaluation Criteria in Solid Tumors) criteria 1.1.

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

- Subject must have adequate bone marrow, renal and hepatic function.

- Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

- Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1,
or radiotherapy within 28 days prior Cycle 1 Day 1.

- More than 2 prior lines of cytotoxic chemotherapy.

- Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP
ribose) Polymerase (PARP) inhibitor.

- Prior taxane therapy for metastatic breast cancer.

- A history of or evidence of brain metastases or leptomeningeal disease.

- A history of uncontrolled seizure disorder.

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

- Known history of allergic reaction to cremophor/paclitaxel.

- Clinical significant uncontrolled conditions, active infection, myocardial infarction,
stroke, or transient ischemic attack, psychiatric illness/social situations that would
limit compliance.

- Pregnant or breastfeeding.

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