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

NCT00129376 | Completed Phase 2 Results

• 1 other identifier: GEICAM 2002-03
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

Stage II and IIIA breast Cancer.; Neoadjuvant chemotherapy.; Weekly docetaxel.

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  Pathological complete response was defined by the Miller \& Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.

  Up to 29 weeks

Secondary Outcomes (4)

• Clinical Response Rate (CRR)

  Up to 29 weeks

• Number of Participants With Over-expression of Topo II (>10% Cells With Nuclear Staining)

  Up to 29 weeks

• Number of Participants With Over-expression of Survivin (>1% Cells With Nuclear Staining)

  Up to 29 weeks

• Number of Participants With Over-expression of p27 (>75% Cells With Nuclear Staining)

  Up to 29 weeks

Study Arms (1)

Doxorubicin+cyclophosphamide - Docetaxel

EXPERIMENTAL

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: Doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel

Interventions

Doxorubicin DRUG

Also known as: adriamycin

Doxorubicin+cyclophosphamide - Docetaxel

Cyclophosphamide DRUG

Also known as: Cytoxan

Doxorubicin+cyclophosphamide - Docetaxel

Docetaxel DRUG

Also known as: Taxotere

Doxorubicin+cyclophosphamide - Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Spanish Breast Cancer Research Group (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); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (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.

You may not qualify if:

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

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Sanofi: collaborator

Study Sites (6)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital de la Ribera

Alzira, Valencia, 46600, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Links

• Click here for more information about this study: GEICAM 2002-03

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Scientific Director / Medical Lead / Project Manager
• Organization: Spanish Breast Cancer Research Group

geicam@geicam.org

+34916592870

Study Officials

• Study Director

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  STUDY DIRECTOR

• Study Director

  Hospital Universitario Marqués de Valdecilla

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 11, 2005
• Study Start: February 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: February 1, 2010
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

ES (6)