NCT00975676

Brief Summary

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels. PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable breast-cancer

Geographic Reach
8 countries

24 active sites

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

November 25, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

October 25, 2021

Completed
Last Updated

October 25, 2021

Status Verified

September 1, 2021

Enrollment Period

8 years

First QC Date

September 10, 2009

Results QC Date

May 14, 2021

Last Update Submit

September 27, 2021

Conditions

Breast Cancer

Keywords

estrogen receptor-positive breast cancerprogesterone receptor-positive breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

  • Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy

    Estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.

    0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

  • Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression

    Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.

    0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

Secondary Outcomes (5)

  • Comparison of Estrogen Levels at Different Time Points During Treatment

    baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization

  • Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression

    Four years after randomization

  • Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm

    Baseline

  • Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm

    Baseline

  • Endocrine Functions (FSH and LH) Status According to Treatment Assignments

    Less than 12 months, at 12 months

Study Arms (2)

Triptorelin plus tamoxifen

EXPERIMENTAL

Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.

Other: gas chromatography / tandem mass spectometry

Triptorelin plus exemestane

EXPERIMENTAL

Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.

Other: gas chromatography / tandem mass spectometry

Interventions

gas chromatography / tandem mass spectometryOTHER

Determination of estrogen levels through gas chromatography.

Triptorelin plus exemestaneTriptorelin plus tamoxifen

Eligibility Criteria

Age0 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed resected breast cancer * Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required * Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: * Premenopausal PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (24)

Centre Rene Huguenin

Saint-Cloud, France

Location

National Institute of Oncology

Budapest, Hungary

Location

Salvatore Maugeri Foundation

Pavia, Italy

Location

Clinica Oncologica, Policlinico Univeritario

Udine, Italy

Location

INEN (Instituto de Enfermedades Neoplasicas)

Lima, Peru

Location

Centro de Lisboa

Lisbon, Portugal

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital Dr Negrin

Las Palmas de Gran Canaria, Spain

Location

H.U. Arnau de Vilanova

Lleida, Spain

Location

Centro Oncologico Md Anderson

Madrid, Spain

Location

Hospital Ramon Y Cajal

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Son Dureta

Palma, Spain

Location

Hospital Son Llatzer

Palma, Spain

Location

Hospital Sant Joan de Reus

Reus, Spain

Location

Hospital Sant Pau i Santa Tecla

Tarragona, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Instituto Valenciano de Oncologia

Valencia, Spain

Location

Sahlgrenska University Hospital Gothenburg

Gothenburg, Sweden

Location

Kantonsspital Graubünden

Chur, Switzerland

Location

Multidisciplinary Oncology Centre, CHUV

Lausanne, Switzerland

Location

Spital Thun

Thun, Switzerland

Location

Brust-Zentrum

Zurich, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chromatography, Gas

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Head Trial Activities and Deputy Director Dr. Heidi Roschitzki-Voser Organization
Organization
International Breast Cancer Study Group (IBCSG)
heidi.roschitzki@ibcsg.org
+41 31 511 94 00

Study Officials

  • Prudence Francis, MD

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

November 25, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 25, 2021

Results First Posted

October 25, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PE(1)PT(1)IT(2)HU(1)FR(1)CH(4)ES(13)SE(1)