Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2009-04-30

Brief Summary

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Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemcitabine+Doxorubicin+Cisplatin+Surgery

Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)

doxorubicin

Intervention Type DRUG

60 mg/m\^2, IV, every 21 days x 4 cycles (1-4)

cisplatin

Intervention Type DRUG

70 mg/m\^2, IV, every 21 days x 4 cycles (5-8)

surgery

Intervention Type PROCEDURE

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Interventions

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gemcitabine

1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)

Intervention Type DRUG

doxorubicin

60 mg/m\^2, IV, every 21 days x 4 cycles (1-4)

Intervention Type DRUG

cisplatin

70 mg/m\^2, IV, every 21 days x 4 cycles (5-8)

Intervention Type DRUG

surgery

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Intervention Type PROCEDURE

Other Intervention Names

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LY188011 Gemzar

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of breast carcinoma
* No previous chemotherapy, with bidimensionally measurable locally advanced disease
* Adequate performance status (Karnofsky Performance Status \[KPS\] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.

Exclusion Criteria

* Inflammatory breast cancer
* Pregnancy and Breast-feeding
* Serious concomitant disorder or infection
* Previous cancer within the last 5 years or a second primary malignancy.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No