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Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 11, 2005
Last Update Posted: September 8, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Spanish Breast Cancer Research Group

Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).

The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis.

Condition Intervention Phase
Breast Cancer Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Pathological complete response

Secondary Outcome Measures:
  • Clinical response rate
  • Toxicity
  • Disease-free survival
  • Overall survival
  • Molecular markers and correlation with response

Estimated Enrollment: 63
Study Start Date: December 2002
Estimated Study Completion Date: July 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 g/dl.
  • 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 surgery.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129376

Spanish Breast Cancer Research Group
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Study Chair: Laura García-Estévez, MD Spanish Breast Cancer Research Group (GEICAM)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00129376     History of Changes
Other Study ID Numbers: GEICAM 2002-03
First Submitted: August 10, 2005
First Posted: August 11, 2005
Last Update Posted: September 8, 2005
Last Verified: August 2005

Keywords provided by Spanish Breast Cancer Research Group:
Stage II and IIIA breast Cancer.
Neoadjuvant chemotherapy.
Weekly docetaxel.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors