Trial · Interventional

CompletedNot applicableResults postedRegistry data

Study of 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 24-02

Short name SOFT-EST

NCTNCT00975676Other idCDR0000650841Other idIBCSG 24-02-SOFT-ESTOther idSOLTI 0801Other idBIG 2-02

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 123 participants (actual)
Sponsor: ETOP IBCSG Partners Foundation · Network
Design: Randomized · Open label (no masking)
Countries: 8 countries
France, Hungary, Italy, Peru, Portugal, Spain, Sweden, Switzerland
Start: 25 Nov 2008
Primary completion: Dec 2016
Completion: Dec 2016
First posted: 11 Sept 2009 (estimated)
Last update posted: 25 Oct 2021
Conditions: Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082010201220142016

N/A
SOFT-EST
NCT00975676
25 Nov 2008 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

gas chromatography / tandem mass spectometryOther

Arms2

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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
Time frame · 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Registry description
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.
Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
Time frame · 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Registry description
Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.

Secondary outcomes(5)

Comparison of Estrogen Levels at Different Time Points During Treatment
Time frame · baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
Registry description
Percent (%) change of estrogen levels estradiol (E2), estrone (E1), and estrone sulphate (E1S) at each timepoint from baseline: e.g. {E2(t)-E2(0)} / E2(0)\*100, where t= 3, 6, 12, 18, 24, 36, and 48 months from randomization
Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression
Time frame · Four years after randomization
Registry description
Potential predictive factors of ineffective estrogen suppression (SES) (with E2 \> 2.72 pg/mL, or any vaginal bleeding \> 3 months after triptorelin start or pregnancy) such as: age, evidence of menses at entry, BMI, chemotherapy (yes/no), and, type of chemotherapy received
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
Time frame · Baseline
Registry description
The secondary analysis explored baseline estrogen levels (E2, E1, E1S) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
Time frame · Baseline
Registry description
The secondary analysis explored endocrine functions (FSH, LH) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Endocrine Functions (FSH and LH) Status According to Treatment Assignments
Time frame · Less than 12 months, at 12 months
Registry description
Endocrine function (FSH, LH) status according to treatment assignments at 12 months using 12 month data alone or 12 month data plus earlier data (when 12 month not available)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (pg/mL)	Spread
Triptorelin Plus Tamoxifen	109.81	119.151
Triptorelin Plus Exemestane	96.55	151.235

Primary outcomeCount of participants· 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression

Group	Value (Participants)
Triptorelin Plus Exemestane	74

Secondary and other outcome results(5)

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

Comparison of Estrogen Levels at Different Time Points During Treatment

Group	Value (percent change of estrogen levels)	Spread
Triptorelin Plus Tamoxifen	0	0
Triptorelin Plus Exemestane	0	0

Secondary outcomeCount of participants· Four years after randomization

Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression

Group	Value (Participants)
Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (E2>2.72 pg/mL)	3
Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (E2>2.72 pg/mL)	5

Secondary outcomeMedian· Baseline

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

Group	Value (pg/mL)
Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL	80
Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL	39

Secondary outcomeMedian· Baseline

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

Group	Value (IU/L)
Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL	6
Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL	32

Secondary outcomeMedian· Less than 12 months, at 12 months

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

Group	Value (IU/L)
Triptorelin Plus Tamoxifen	2.0
Triptorelin Plus Exemestane	7.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Triptorelin Plus TamoxifenDetermination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.	0 / 0	0 / 0	0 / 0
Triptorelin Plus ExemestaneDetermination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.	0 / 0	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 0 Years up to 120 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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