NCT01026116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2016

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

6.1 years

First QC Date

December 3, 2009

Last Update Submit

May 9, 2020

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • overall survival

    every one year

Study Arms (2)

EC-wP

ACTIVE COMPARATOR

epirubicin/cyclophosphamide followed weekly paclitaxel

Drug: EpirubicinDrug: CyclophosphamideDrug: Paclitaxel

EP-wP

EXPERIMENTAL

epirubicin/paclitaxel followed by weekly paclitaxel

Drug: EpirubicinDrug: CyclophosphamideDrug: Paclitaxel

Interventions

EpirubicinDRUG

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

EC-wPEP-wP
CyclophosphamideDRUG

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

EC-wPEP-wP
PaclitaxelDRUG

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

EC-wPEP-wP

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • % 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Breast Surgery, Cancer Hospital, Fudan University

Shanghai, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 33822134DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EpirubicinCyclophosphamidePaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Zhimin Shao

    Cancer Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Breast Surgery Department

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2016

Study Completion

December 23, 2016

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

CN(1)