A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Doxorubicin; Drug: CMF; Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01998906

MO16432

Details and patient eligibility

About

This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.

Enrollment: 330 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients, >=18 years of age, with locally advanced breast cancer.

Exclusion criteria

• previous therapy for any invasive malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups

HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF

Experimental group

Description:

Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m\^2, IV; methotrexate 40 mg/m\^2, IV; and 5-fluorouracil 600 mg/m\^2, IV, on Day 1 of Cycles 8 through 10.

Treatment:

Drug: CMF

Drug: Trastuzumab

Drug: Doxorubicin

Drug: Paclitaxel

HER-2+ Doxorubicin/Paclitaxel/CMF

Active Comparator group

Description:

Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.

Treatment:

Drug: CMF

Drug: Doxorubicin

Drug: Paclitaxel

HER-2- Doxorubicin/Paclitaxel/CMF

Active Comparator group

Description:

Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.

Treatment:

Drug: CMF

Drug: Doxorubicin

Drug: Paclitaxel