Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women Who Are Undergoing Surgery for Early Breast Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: cyclophosphamide (Drug); epirubicin hydrochloride (Drug); gemcitabine hydrochloride (Drug); paclitaxel (Drug); comparative genomic hybridization (Genetic); microarray analysis (Genetic); mutation analysis (Genetic); conventional surgery (Procedure); neoadjuvant therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Cambridge University Hospitals NHS Foundation Trust Official(s) and/or principal investigator(s): Helena Earl, MBBS, PhD, FRCP, Affiliation: Cambridge University Hospitals NHS Foundation Trust
Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and
gemcitabine use different ways to stop tumor cells from dividing so they stop growing or
die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be
removed during surgery. It is not yet known which combination chemotherapy regimen is more
effective in treating early breast cancer.
PURPOSE: This randomized phase III trial is studying different regimens of combination
chemotherapy to compare how well they work in treating women who are undergoing surgery for
early invasive breast cancer.
Clinical Details
Official title: A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer
Study design: Allocation: Randomized, Primary Purpose: Treatment
Primary outcome: Complete pathological response after 4 courses
Secondary outcome: SurvivalDisease-free survival Effect of prognostic factors
Detailed description:
OBJECTIVES:
Primary
- Compare the complete pathological response rate in women with poor-risk early breast
cancer treated with neoadjuvant sequential epirubicin, cyclophosphamide, and paclitaxel
with vs without gemcitabine.
Secondary
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the effect of these regimens on prognostic factors in these patients.
- Correlate molecular profiles, specific gene mutations, and genomic and gene expression
changes with clinical outcome in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the health economics associated with this study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
estrogen-receptor status (negative vs greater than 10% positive cells), HER-2 status
(positive vs negative), tumor size (30-50 mm vs greater than 50 mm), and clinical
involvement of axillary nodes (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Neoadjuvant sequential chemotherapy:
- Arm I: Patients receive epirubicin IV and cyclophosphamide IV on day 1. Treatment
repeats every 21 days for 4 courses. Patients then receive paclitaxel IV over 3
hours on day 1. Treatment repeats every 21 days for 4 courses.
- Arm II: Patients receive paclitaxel as in arm I followed by epirubicin and
cyclophosphamide as in arm I.
- Arm III: Patients receive epirubicin and cyclophosphamide as in arm I followed by
paclitaxel as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for 4 courses.
- Arm IV: Patients receive paclitaxel as in arm I and gemcitabine as in arm III
followed by epirubicin and cyclophosphamide as in arm I.
- Surgery: After completion of neoadjuvant chemotherapy, patients in all arms undergo
definitive surgery.
Tumor tissue is removed from a subset of patients during serial biopsies. Molecular and
genetic profiling, mutation analysis, and comparative genomic analysis is performed on the
tissue samples.
Quality of life is assessed at baseline, after 4 courses of chemotherapy, after the
completion of chemotherapy, after surgery, and then every 6 months for 2 years.
Patients are followed every 2 months for 2 years and then every 3 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 800 patients (200 per treatment arm) will be accrued for this
study.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Grade 2 or 3
- Tumor size at least 3 cm by ultrasound
- No evidence of metastatic disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Not specified
Sex
- Female
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Fit to receive study chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Locations and Contacts
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England CB2 2QQ, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2005
Last updated: August 6, 2013
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