A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old
NCT ID: NCT01026116
Last Updated: 2020-05-12
Study Results
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Basic Information
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COMPLETED
PHASE3
521 participants
INTERVENTIONAL
2009-12-31
2016-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EC-wP
epirubicin/cyclophosphamide followed weekly paclitaxel
Epirubicin
75 mg/m2 every-3-week for four cycles
Cyclophosphamide
600 mg/m2 every-3-week for four cycles
Paclitaxel
175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
EP-wP
epirubicin/paclitaxel followed by weekly paclitaxel
Epirubicin
75 mg/m2 every-3-week for four cycles
Cyclophosphamide
600 mg/m2 every-3-week for four cycles
Paclitaxel
175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
Interventions
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Epirubicin
75 mg/m2 every-3-week for four cycles
Cyclophosphamide
600 mg/m2 every-3-week for four cycles
Paclitaxel
175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Director of Breast Surgery Department
Principal Investigators
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Zhimin Shao
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Fudan University
Locations
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Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, , China
Countries
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References
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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.
Other Identifiers
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SHBCC09007
Identifier Type: -
Identifier Source: org_study_id
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