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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00129376
First received: August 10, 2005
Last updated: September 7, 2005
Last verified: August 2005
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129376

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00129376     History of Changes
Other Study ID Numbers: GEICAM 2002-03
Study First Received: August 10, 2005
Last Updated: September 7, 2005
Health Authority: Spain: Spanish Agency of Medicines

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
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014