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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00516425
First received: August 14, 2007
Last updated: August 6, 2013
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Genetic: proteomic profiling
Other: 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
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Cytotoxic Chemotherapy In Older Women

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Relapse-free interval [ Designated as safety issue: No ]
  • Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI) [ Designated as safety issue: No ]
  • Total FACT-AN score [ Designated as safety issue: No ]
  • Total FACT-F score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Cause-specific survival [ Designated as safety issue: No ]
  • Distant disease-free survival [ Designated as safety issue: No ]
  • Safety and tolerability (overall and for each treatment schedule) [ Designated as safety issue: Yes ]
  • Treatment compliance (overall and for each treatment schedule) [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Total FACT-B score [ Designated as safety issue: No ]
  • Individual subscales on activities of daily living [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2007
Detailed Description:

OBJECTIVES:

  • To provide evidence for extending the current standard care in older women with invasive breast carcinoma treated with adjuvant chemotherapy comprising doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide.
  • Compare the relapse-free survival interval of these patients treated with adjuvant chemotherapy vs no adjuvant chemotherapy.
  • Compare the toxicity of accelerated adjuvant chemotherapy with pegfilgrastim support vs non-accelerated adjuvant chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and indication for endocrine therapy (yes vs no). Patients are randomized to 1 of 2 arms.

  • Arm I (observation): Patients do not receive adjuvant chemotherapy.
  • Arm II (adjuvant chemotherapy): Patients are randomized to 1 of 2 chemotherapy regimens.

    • Accelerated adjuvant chemotherapy: Patients receive doxorubicin hydrochloride and cyclophosphamide (AC) OR epirubicin hydrochloride and cyclophosphamide (EC) on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
    • Non-accelerated adjuvant chemotherapy: Patients receive AC or EC on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection for biological, pharmacological, and proteomic studies. Samples are initially used to establish a resource of materials available for different research groups. Samples are also analyzed using SELDI or MALDI-ToF technology to identify biological profiles that correlate with prognosis or predict response to treatment.

Quality of life is assessed at baseline, 6 weeks, 1 month, 6 months, 9 months, 12 months, 18 months, and 24 months.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00516425

Locations
United Kingdom
Charing Cross Hospital Recruiting
London, England, United Kingdom, W6 8RF
Contact: Robert C.F. Leonard, MD, BS, MB    44-208-846-7237      
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Contact: Anne Robinson, MD    44-1702-221-226      
Sponsors and Collaborators
Charing Cross Hospital
Investigators
Principal Investigator: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00516425     History of Changes
Other Study ID Numbers: UKM-CCH-ACTION, CDR0000561076, ICR-CTSU/2006/10004-ACTION, EU-20751, EUDRACT-2005-005721, ISRCTN41708421, BIG-205
Study First Received: August 14, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Epirubicin
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014