Clinical trial NCT01026116: A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old
Official title: Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 521
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: disease-free survival
timeFrame: every one year
measure: menstrual resumption rate
timeFrame: 12 months after chemotherapy
Secondary outcomes:
measure: overall survival
timeFrame: every one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Breast Surgery, Cancer Hospital, Fudan University
Study officials:
affiliation: Cancer Hospital, Fudan University
name: Zhimin Shao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.