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Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer.


Inclusion Criteria:



- Female patients, >/= 18 years of age

- Metastatic breast cancer

- Estrogen receptor- , progesterone- and HER2-negative disease

- Treatment-naïve for metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Prior first line treatment for metastatic breast cancer

- CNS metastasis

- Uncontrolled hypertension (> 170/95 mmHg)

- Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline

- History of other malignant disease within past 3 years, except for curatively treated
basal cell carcinoma of the skin and carcinoma in situ of the cervix

- Prior therapy with gemcitabine or carboplatin in the metastatic setting. Patients
having received gemcitabine or carboplatin as part of adjuvant therapy are eligible,
if recurrence was first documented >6 months after the last exposure to the drug(s)

- Requirement of chronic use of immunosuppressive agents

- HIV, hepatitis B or hepatitis C infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS), according to RECIST criteria, assessments by CT/MRI/bone scans and X-ray

Outcome Time Frame:

approximately 3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

India: Ministry of Health

Study ID:

ML25420

NCT ID:

NCT01201265

Start Date:

February 2011

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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