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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516425
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 15, 2007
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment 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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Cytotoxic Chemotherapy In Older Women
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Relapse-free interval
  2. Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI)
  3. Total FACT-AN score
  4. Total FACT-F score

Secondary Outcome Measures :
  1. Disease-free survival
  2. Overall survival
  3. Cause-specific survival
  4. Distant disease-free survival
  5. Safety and tolerability (overall and for each treatment schedule)
  6. Treatment compliance (overall and for each treatment schedule)
  7. Quality of life
  8. Total FACT-B score
  9. Individual subscales on activities of daily living

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00516425

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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
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Principal Investigator: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
Layout table for additonal information Identifier: NCT00516425    
Other Study ID Numbers: UKM-CCH-ACTION
CDR0000561076 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2007
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal 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
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors