Know Cancer

or
forgot password

Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study


Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative)
does not respond to hormonal or biological therapy with trastuzumab. However, triple
negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel
and carboplatin administered on a weekly basis is active and well tolerated. Recently,
initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated
prolonged progression-free survival, as compared with paclitaxel alone


Inclusion Criteria:



- Histologically or cytologically confirmed metastatic breast adenocarcinoma

- No HER2 overexpression or gene amplification

- Absent or low ER or PR expression

- No previous therapy for metastatic breast cancer is allowed

- Age 18-75 years

- Measurable disease as defined by the presence of at least one measurable lesion
(except bone metastases, ascites or pleural effusions)

- Performance status (WHO) 0-2

- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT
<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or
<5 times the upper normal limit in the presence of liver metastases)

- adequate renal function (serum creatinine <1.5 times the upper normal limit)

- bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

- No radiation of measurable disease (except brain metastases)

- No progressive brain metastases according to clinical or radiological criteria

- No brain metastases without prior radiation therapy

- Written informed consent

Exclusion Criteria:

- Active infection

- History of significant cardiac disease (unstable angina, congestive heart failure,
myocardial infarction within the previous 6 months, ventricular arrhythmias)

- History of stroke

- Anticoagulation therapy (except of low dose aspirin <325mg)

- Other invasive malignancy except nonmelanoma skin cancer

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

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:

Overall Response Rate

Outcome Time Frame:

Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/08.02

NCT ID:

NCT00691379

Start Date:

April 2008

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Triple negative
  • Chemotherapy
  • Anti-angiogenesis therapy
  • Breast Neoplasms

Name

Location