A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Herceptin; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191451

B9E-US-S359

9397

Details and patient eligibility

About

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of metastatic breast cancer
2. Able to visit the doctor's office at least every 14 days during the actual treatment
3. Able to care for yourself, even if you cannot work or participate in other normal activities
4. Your blood results must be adequate for therapy.
5. If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.

Exclusion criteria

1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
2. Be pregnant or breastfeeding
3. Have cancer to the brain and has not been treated
4. Have another active cancer besides breast cancer
5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

HER2+

Experimental group

Description:

Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.

Treatment:

Drug: Herceptin

Drug: Carboplatin

Drug: Gemcitabine

HER2- (Taxane-)

Experimental group

Description:

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).

Treatment:

Drug: Carboplatin

Drug: Gemcitabine

HER2- (Taxane+)

Experimental group

Description:

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).

Treatment:

Drug: Carboplatin

Drug: Gemcitabine