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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
pegfilgrastim
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
proteomic profiling
diagnostic laboratory biomarker analysis
matrix-assisted laser desorption/ionization time of flight mass spectrometry
pharmacological study
surface-enhanced laser desorption/ionization-time of flight mass spectrometry
adjuvant therapy
Sponsored by
Charing Cross Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Charing Cross HospitalRecruiting
  • Southend University Hospital NHS Foundation TrustRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
August 14, 2007
Last Updated
August 6, 2013
Sponsor
Charing Cross Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00516425
Brief Title
Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer
Official Title
Adjuvant Cytotoxic Chemotherapy In Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Charing Cross Hospital

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Genetic
Intervention Name(s)
proteomic profiling
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
matrix-assisted laser desorption/ionization time of flight mass spectrometry
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Other
Intervention Name(s)
surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Relapse-free interval
Title
Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI)
Title
Total FACT-AN score
Title
Total FACT-F score
Secondary Outcome Measure Information:
Title
Disease-free survival
Title
Overall survival
Title
Cause-specific survival
Title
Distant disease-free survival
Title
Safety and tolerability (overall and for each treatment schedule)
Title
Treatment compliance (overall and for each treatment schedule)
Title
Quality of life
Title
Total FACT-B score
Title
Individual subscales on activities of daily living

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C.F. Leonard, MD, BS, MB
Organizational Affiliation
Charing Cross Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert C.F. Leonard, MD, BS, MB
Phone
44-208-846-7237
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Robinson, MD
Phone
44-1702-221-226

12. IPD Sharing Statement

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

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