A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old

Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old

Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Department of Breast Surgery, Cancer Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients, age 18~40
• Unilateral, operable, histologically confirmed adenocarcinoma of the breast
• Stage I-III
• Primary surgery with clear margins plus axillary dissection
• Able to start protocol Rx within 8 weeks of surgery

• Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer: the immunohistochemical cut-off for ER positive status was

  1% or more staining in nuclei

• HER-2 negative (IHC 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy
• pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter >10 mm when histological grade III, or tumor diameter >20 mm when histological grade II)
• ECOG performance status 0-1
• Adequate cardiac, renal, hepatic and hematologic function

Exclusion Criteria:

• Metastatic disease
• Bilateral breast cancer (synchronous or metachronous)
• Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
• Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
• HER-2 positive (IHC 3+ OR FISH+) and or triple-negative breast cancer
• Documented history of cardiac disease contradiction anthracyclines
• Concurrent serious illness
• Peripheral neuropathy of CTC grade>1
• History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EC-wP; epirubicin/cyclophosphamide followed weekly paclitaxel	Drug: Epirubicin; 75 mg/m2 every-3-week for four cycles; Drug: Cyclophosphamide; 600 mg/m2 every-3-week for four cycles; Drug: Paclitaxel; 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
Experimental: EP-wP; epirubicin/paclitaxel followed by weekly paclitaxel	Drug: Epirubicin; 75 mg/m2 every-3-week for four cycles; Drug: Cyclophosphamide; 600 mg/m2 every-3-week for four cycles; Drug: Paclitaxel; 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival		every one year
menstrual resumption rate	Resumption of menses was defined as at least 2 consecutive menstruations, or at least 1 menstruation with a confirmed premenopausal level of FSH and estradiol after chemotherapy	12 months after chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	every one year

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Zhimin Shao, Cancer Hospital, FuDan University

Publications and helpful links

General Publications

• Yu KD, Ge JY, Liu XY, Mo M, He M, Shao ZM; SPECTRUM Investigators. Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial. J Natl Cancer Inst. 2021 Oct 1;113(10):1352-1359. doi: 10.1093/jnci/djab065.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): December 23, 2016

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Paclitaxel; Epirubicin
• Other Study ID Numbers: SHBCC09007