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NCT00066807: PERCHE

A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy

Terminated Phase 3 Results posted Last updated 26 September 2016
What this trial tests

Phase 3 trial testing chemotherapy in Breast Cancer in 29 participants. Terminated before completion.

Timeline
1 August 2003
Primary endpoint
1 December 2006
1 December 2006

Quick facts

Lead sponsorETOP IBCSG Partners Foundation
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment29
Start date1 August 2003
Primary completion1 December 2006
Estimated completion1 December 2006
Sites6 locations across Hungary, Italy, Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

ETOP IBCSG Partners Foundation

Who can join

Adults 18 to 65, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial \[recommended option\]. The trial was terminated early due to poor accrual.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Long term side effects of adjuvant chemotherapy in patients with early breast cancer.
    Tao JJ, Visvanathan K, Wolff AC. · · 2015 · cited 151× · PMID 26299406 · DOI 10.1016/j.breast.2015.07.035
  2. Aromatase inhibitors in premenopausal women with breast cancer: the state of the art and future prospects.
    Pistelli M, Mora AD, Ballatore Z, Berardi R. · · 2018 · cited 40× · PMID 29719441 · DOI 10.3747/co.25.3735

Verify or expand the search:

Other trials of chemotherapy

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other ETOP IBCSG Partners Foundation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00066807.

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