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

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ClinicalTrials.gov Identifier: NCT00129376
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Actual Study Start Date : February 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Doxorubicin+cyclophosphamide - Docetaxel
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles. Later, docetaxel (36 mg/m2) was administered an intravenous infusion, weekly for six weeks followed by a 2-week resting period (8-week cycle).
Drug: docetaxel
Other Names:
  • doxorubicin
  • cyclophosphamide



Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: up to 24 weeks ]
    Defined by the Miller & Payne criteria


Secondary Outcome Measures :
  1. Clinical response rate [ Time Frame: up to 24 weeks ]
    The clinical response is measured according to the RECIST criteria.

  2. Toxicity [ Time Frame: up to 12 weeks ]
    Is measured according to the scale of the NCI version 2.0

  3. Disease-free survival [ Time Frame: From date of randomization until the date of first documented progression (if it is applicable), assessed up to 72 months ]
    Interval from the date of registration in the study to the date of local, regional or metastatic recurrence or the date on which the second primary cancer manifests or death occurs for any reason, depending on the circumstance that occurs first .

  4. Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 72 months ]
    Interval from the date of registration in the study to the date in which the death occurs for any reason.

  5. Molecular markers and correlation with response [ Time Frame: through study completion, an average of 2 years ]
    The predictive response markers will be determined by the usual techniques



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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.

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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


Locations
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital de la Ribera
Alcira, Valencia, Spain, 46600
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Sanofi
Investigators
Study Director: Study Director Fundación Jiménez Díaz
Study Director: Study Director Hospital Universitario Marqués de Valdecilla

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00129376     History of Changes
Other Study ID Numbers: GEICAM 2002-03
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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
Liposomal doxorubicin
Doxorubicin
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