Clinical trial · Interventional
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
NCT01026116CI-TRIAL-00045065completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EC-wP
- description
- epirubicin/cyclophosphamide followed weekly paclitaxel
- interventionNames
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- EP-wP
- description
- epirubicin/paclitaxel followed by weekly paclitaxel
- interventionNames
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYu 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. PMID 33822134