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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EC-wP | Active Comparator | epirubicin/cyclophosphamide followed weekly paclitaxel |
|
| EP-wP | Experimental | epirubicin/paclitaxel followed by weekly paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin | Drug | 75 mg/m2 every-3-week for four cycles |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | every one year |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Shao | Cancer Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Breast Surgery, Cancer Hospital, Fudan University | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33822134 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| Cyclophosphamide |
| Drug |
600 mg/m2 every-3-week for four cycles |
|
| Paclitaxel | Drug | 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |