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Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastatic

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Trial Information

Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)


The duration of the study for a patient includes a period for inclusion of up to 3 weeks.
The patients may continue treatment until disease progression, unacceptable toxicity or
consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment
administration.

In case of discontinuation of study treatment, the patient will be considered as withdrawn
from study treatment, and will be followed as planned for at least 30 days after the last
administration of study treatment for safety purpose. In case of study treatment
discontinuation without disease progression, efficacy data will be collected every 6 weeks
until disease progression, death or end of study whatever comes first. After disease
progression, the patient will be followed-up every 12 weeks (3 months) for overall survival
until death or end of study.

The patients who benefit from the study treatment can continue until disease progression,
toxicity or willingness to stop.

Inclusion Criteria


Inclusion criteria:

- Histologically documented breast cancer (either primary or metastatic site) that is:

- ER (Estrogen Receptor)- negative, PR (Progesterone Receptor)-negative (for ER-
and PR-negative: <10% tumor staining by immunohistochemistry [IHC]) AND

- Human Epidermal Growth Factor 2 (HER2) non-overexpressing by IHC (0,1+) or, IHC
2+ and Fluorescence In Situ Hybridization (FISH negative). Patients IHC 3+ are
not eligible;

- Metastatic breast cancer with measurable disease by the revised guideline for
Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1 criteria);

- Prior treatment that includes:

- never having received anticancer therapy for metastatic disease OR

- having received 1 or 2 prior chemotherapy regimens in the metastatic setting
(prior neo-adjuvant/adjuvant systemic therapy is considered as a prior
chemotherapy if the first relapse occurred less than one year after the last
treatment administration);

Exclusion criteria:

- Prior treatment with gemcitabine, carboplatin, cisplatin or any PARP inhibitor;

- Bone metastasis as only disease location (except for bone metastasis with measurable
soft tissue component);

- Major medical conditions that might affect study participation e.g., uncontrolled
pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR) as defined in the RECIST 1.1 version, as: complete response (CR) rate and partial response (PR) rate

Outcome Time Frame:

up to a maximum follow up of 14 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

TCD11418

NCT ID:

NCT01045304

Start Date:

February 2010

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer, Metastatic
  • Breast Neoplasms

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