Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer

NCT00516425 | Unknown Phase 3

• 7 other identifiers: UKM-CCH-ACTIONCDR0000561076ICR-CTSU/2006/10004-ACTIONEU-20751EUDRACT-2005-005721ISRCTN41708421BIG-205
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide, 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 after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving doxorubicin or epirubicin together with cyclophosphamide is more effective than observation in treating older women with invasive breast cancer. PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and cyclophosphamide to see how well they work compared with observation in treating older women with invasive breast cancer.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (4)

• Relapse-free interval

• Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI)

• Total FACT-AN score

• Total FACT-F score

Secondary Outcomes (9)

• Disease-free survival

• Overall survival

• Cause-specific survival

• Distant disease-free survival

• Safety and tolerability (overall and for each treatment schedule)

Interventions

pegfilgrastim BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

proteomic profiling GENETIC

diagnostic laboratory biomarker analysis OTHER

matrix-assisted laser desorption/ionization time of flight mass spectrometry OTHER

pharmacological study OTHER

surface-enhanced laser desorption/ionization-time of flight mass spectrometry OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast carcinoma * Primary operable breast cancer that was surgically treated by wide local excision or mastectomy with clear margins (\> 1 mm apart from deep margin if full thickness resection) * No more than 8 weeks since prior definitive surgery * Early-stage disease with no evidence of metastases clinically or on routine staging investigations * No T4 and/or N3 disease * Prior axillary staging required, including 1 of the following: * Sentinel node biopsy * Axillary sampling or clearance * All node-positive patients must have had axillary clearance or radiotherapy to the axilla * Must be at high risk of relapse within 5 years (risk factors evaluated at clinician's discretion) * No other invasive breast cancer, systemically treated ductal carcinoma in situ (DCIS), or solid tumor within the past 5 years * No prior hematologic malignancy or melanoma * Hormone receptor status: * Estrogen receptor (ER)- or progesterone receptor (PR)-negative OR ER/PR-weakly positive (e.g., Allred/Quick score ≤ 5 OR H score ≤ 100) PATIENT CHARACTERISTICS: * Female * Postmenopausal * Performance status 0-1 * Hemoglobin \> 9 g/dL * WBC \> 3,000/mm³ * Platelet count \> 100,000/mm³ * Bilirubin normal (unless known Gilbert's disease is present) * Albumin normal * AST and ALT ≤ 1.5 x upper limit of normal (ULN) * Creatinine ≤ 1.5 x ULN * Creatinine clearance \> 50 mL/min * No active or uncontrolled infection * Must be available for routine long-term hospital follow-up * Must have normal cardiac function and no significant cardiac disease by ECHO or MUGA PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior preoperative endocrine therapy * No prior systemic therapy for this breast cancer or mantle radiotherapy * No prior breast-conserving surgery in which there is a contraindication for, or decline of postoperative radiotherapy * No concurrent hormone replacement therapy (HRT)

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

Sponsors & Collaborators

• Charing Cross Hospital: lead

Study Sites (2)

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

RECRUITING

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastim; Cyclophosphamide; Doxorubicin; Epirubicin; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Chemotherapy, Adjuvant

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; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Mass Spectrometry; Chemistry Techniques, Analytical; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Robert C.F. Leonard, MD, BS, MB

  Charing Cross Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: January 1, 2007
• Last Updated: August 7, 2013

Record last verified: 2007-09

Locations

GB (2)