Clinical Trials /

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

NCT00516425

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer
  • Official Title: Adjuvant Cytotoxic Chemotherapy In Older Women

Clinical Trial IDs

  • ORG STUDY ID: UKM-CCH-ACTION
  • SECONDARY ID: CDR0000561076
  • SECONDARY ID: ICR-CTSU/2006/10004-ACTION
  • SECONDARY ID: EU-20751
  • SECONDARY ID: EUDRACT-2005-005721
  • SECONDARY ID: ISRCTN41708421
  • SECONDARY ID: BIG-205
  • NCT ID: NCT00516425

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
pegfilgrastim
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:70 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse-free interval
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Secondary Outcome Measures

Measure:Disease-free survival
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Measure:Overall survival
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Measure:Cause-specific survival
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Measure:Distant disease-free survival
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Description:
Measure:Safety and tolerability (overall and for each treatment schedule)
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Description:
Measure:Treatment compliance (overall and for each treatment schedule)
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Measure:Quality of life
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Description:
Measure:Total FACT-B score
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Measure:Individual subscales on activities of daily living
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Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Charing Cross Hospital

Trial Keywords

  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer

Last Updated

August 6, 2013