Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery

NCT00801411 | Unknown Phase 2

• 3 other identifiers: CDR0000624374SINGAPORE-NCC0705SANOFI-AVENTIS-NCC0705
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer. PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

Secondary Outcomes (4)

• Clinical and pathological overall response rate

• Toxicity as assessed by NCI CTCAE v3.0

• Overall survival

• Disease-free survival

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.

Drug: cyclophosphamide; Drug: docetaxel

Arm II

ACTIVE COMPARATOR

Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride

Interventions

cyclophosphamide DRUG

Given IV

Arm I; Arm II

docetaxel DRUG

Given IV

Arm I

doxorubicin hydrochloride DRUG

Given IV

Arm II

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Newly diagnosed disease * Operable disease * Must have clinical T2 (\> 2cm) or T3 (\> 5 cm) primary tumors with no clinical lymph node involvement (N0) * No clinical T4 lesion (e.g., peau d'orange, skin ulceration, satellite nodules, or inflammatory breast cancer) * No evidence of metastatic disease * Known hormone receptor status PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%) * Life expectancy \> 10 years * Leukocytes ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine normal or creatinine clearance ≥ 40 mL/min * Normal cardiac ejection fraction, defined as ≥ 50% by MUGA scan or 2D-ECHO * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or other agents used in this study * No history of pre-existing peripheral neuropathy * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * No prior malignancies except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No other concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy * No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, surgery for cancer, or experimental medications * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent antitumor therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

National Cancer Centre - Singapore

Singapore, 169610, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wong Nan Soon, MBBS, MRCP, FAMS

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: October 1, 2008
• Last Updated: June 17, 2009

Record last verified: 2009-06

Locations

SG (2)