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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026116

Enrollment

521

Registered

2009-12-04

Start date

2009-12-31

Completion date

2016-12-23

Last updated

2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

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.

Interventions

DRUGEpirubicin

75 mg/m2 every-3-week for four cycles

DRUGCyclophosphamide

600 mg/m2 every-3-week for four cycles

DRUGPaclitaxel

175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival	every one year	—
menstrual resumption rate	12 months after chemotherapy	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

Secondary

Measure	Time frame
overall survival	every one year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026