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Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients

Phase 2
18 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients

Inclusion Criteria:

- Written informed consent.

- Patients with breast cancer stages II and IIIA, with histological diagnoses as per
true-cut or open biopsy.

- Negative extension study, including bilateral mammography, thoracic x-ray, computed
tomography (CT)-scan or abdominal echography and bone scintigraphy.

- Analysis of hormone receptor status in primary tumour. It is highly recommended to
obtain a tumour tissue sample before start of treatment, and after definitive
surgery. These samples will be analysed centrally by GEICAM.

- Age >= 18 and <= 70 years old.

- Performance status as per Karnofsky index >= 80.

- Minimum life expectancy of 6 months.

- Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities
are suspected, cardiac function must be assessed by left ventricular ejection
fraction (LVEF).

- Haematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >=10

- Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); SGOT and SGPT <=
2.5 x UNL; alkaline phosphatase <= 5 x UNL.

- Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min.

- Patients able to comply with study requirements.

- Negative pregnancy test.

- Adequate contraceptive method during the study and up to 3 months after definitive

Exclusion Criteria:

- Previous systemic therapy for breast cancer treatment.

- Previous treatments with anthracyclines or taxanes for any malignancy.

- Previous radiotherapy for breast cancer.

- Bilateral invasive breast cancer.

- Pregnant or lactating women.

- Previous motor or sensorial neurotoxicity grade >=2.

- Other serious pathologies: congestive heart failure or angina pectoris; history of
myocardial infarction in the previous year; uncontrolled hypertension (HT) or high
risk arrhythmias.

- History of neurological or psychiatric impairment, precluding patients from providing
free informed consent.

- Active infection.

- Active peptic ulcer; unstable diabetes mellitus.

- History of previous or current malignancies other than breast cancer, except for
basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated
more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in
situ (LCIS).

- Chronic treatment with corticoids unless the treatment started > 6 months before
registration to the study, and low doses are administered.

- Substitutive hormonal therapy. This treatment must be interrupted before inclusion in
the study.

- Concomitant treatment with other investigational products or administration in the 30
previous days.

- Males.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response

Principal Investigator

Laura García-Estévez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Research Group (GEICAM)


Spain: Spanish Agency of Medicines

Study ID:

GEICAM 2002-03



Start Date:

December 2002

Completion Date:

July 2005

Related Keywords:

  • Breast Cancer
  • Stage II and IIIA breast Cancer.
  • Neoadjuvant chemotherapy.
  • Weekly docetaxel.
  • Breast Neoplasms