Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Epirubicin; Drug: Albumin-bound Paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193206

SCRI BRE 73

Details and patient eligibility

About

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Full description

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Enrollment: 123 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

• Locally advanced/inflammatory adenocarcinoma of the breast
• 18 years of age or older
• Normal heart function
• Able to perform activities of daily living with minimal assistance
• No prior chemotherapy for breast cancer
• Adequate bone marrow, liver and kidney function
• No evidence or history of significant cardiovascular abnormalities
• Sentinel node or axillary dissection
• Sign an informed consent form

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

• Pregnant or breast feeding
• History of heart disease with congestive heart failure
• Heart attack within the previous 6 months
• Prior chemotherapy or hormone therapy for breast cancer
• History of active uncontrolled infection

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Intervention

Experimental group

Description:

Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.

Treatment:

Drug: Gemcitabine

Drug: Albumin-bound Paclitaxel

Drug: Epirubicin