Breast CancerSOFT-ESTNCT00975676

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

A study testing gas chromatography / tandem mass spectometry in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 24 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 0 to 120 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: gas chromatography / tandem mass spectometry
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 24 sitesin 8 countries
Study dates: 25 Nov 2008to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 120 years
Women only
No healthy volunteers
Child, Adult, Older adult

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

Trial locations and contacts

24 sites in 8 countries.

Country

City, postcode or hospital

24 sites in 8 countries

Spain13 sites

Vall d'Hebron University Hospital
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Dr Negrin
Las Palmas de Gran Canaria
H.U. Arnau de Vilanova
Lleida
Centro Oncologico Md Anderson
Madrid
Hospital Ramon Y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Son Dureta
Palma
Hospital Son Llatzer
Palma
Hospital Sant Joan de Reus
Reus
Hospital Sant Pau i Santa Tecla
Tarragona
Hospital Clinico Universitario de Valencia
Valencia
Instituto Valenciano de Oncologia
Valencia

Other trials in Spain

Switzerland4 sites

Kantonsspital Graubünden
Chur
Multidisciplinary Oncology Centre, CHUV
Lausanne
Spital Thun
Thun
Brust-Zentrum
Zurich

Other trials in Switzerland

Italy2 sites

Salvatore Maugeri Foundation
Pavia
Clinica Oncologica, Policlinico Univeritario
Udine

Other trials in Italy

France1 site

Centre Rene Huguenin
Saint-Cloud

Other trials in France

Hungary1 site

National Institute of Oncology
Budapest

Other trials in Hungary

Peru1 site

INEN (Instituto de Enfermedades Neoplasicas)
Lima

Other trials in Peru

Portugal1 site

Centro de Lisboa
Lisbon

Other trials in Portugal

Sweden1 site

Sahlgrenska University Hospital Gothenburg
Gothenburg

Other trials in Sweden

About this study

Official title: A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial

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.

Read the detailed description

OBJECTIVES:

Primary

Describe estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.

Secondary

Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy [yes/no], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.

OUTLINE: This is a multicenter study.

Blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for measurement of estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) by gas chromatography-mass spectrometry and measurement of endocrine function (FSH and LH).

Conditions: Breast Cancer
Being tested: gas chromatography / tandem mass spectometry
Keywords: estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gas chromatography / tandem mass spectometryOther
Determination of estrogen levels through gas chromatography.

Study groups in NCT00975676
Study group	Role	What they receive
Triptorelin plus tamoxifen	Experimental	Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. Receives: 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. Receives: Other: gas chromatography / tandem mass spectometry

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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
Measured: 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
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
Measured: Four years after randomization
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
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.
Measured: Baseline
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
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.
Measured: Baseline
Endocrine Functions (FSH and LH) Status According to Treatment Assignments
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)
Measured: Less than 12 months, at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 2008Dec 2016

First posted11 Sep 2009 (estimated)
Study start25 Nov 2008
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975676
Sponsor's protocol ID: CDR0000650841
Other IDs: IBCSG 24-02-SOFT-EST, SOLTI 0801, BIG 2-02
Acronym: SOFT-EST
Status last verified: Sep 2021
First submitted: 10 Sep 2009
Last updated: 25 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial
ClinicalTrials.gov ID: NCT00975676
Acronym / sponsor ID: SOFT-EST / CDR0000650841
Conditions: Breast Cancer
Keywords: estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: ETOP IBCSG Partners FoundationResearch network
Study start: 25 Nov 2008
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 25 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

Describe estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.

Secondary

Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy [yes/no], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.

OUTLINE: This is a multicenter study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Triptorelin plus tamoxifen	Experimental	Other: gas chromatography / tandem mass spectometryDetermination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
Triptorelin plus exemestane	Experimental	Other: gas chromatography / tandem mass spectometryDetermination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.

Who may qualify

Ages: 0 to 120 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
gas chromatography / tandem mass spectometryDetermination of estrogen levels through gas chromatography.	Other	Triptorelin plus exemestane, Triptorelin plus tamoxifen

Primary outcome

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

5 secondary outcomes

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
Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression
Time frame: Four years after randomization
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
Time frame: Baseline
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
Time frame: Baseline
Endocrine Functions (FSH and LH) Status According to Treatment Assignments
Time frame: Less than 12 months, at 12 months

Results and safety

Results posted to the registry on 25 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triptorelin Plus Tamoxifen	32	26
Triptorelin Plus Exemestane	91	83

Primary outcome: 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. Mean (Standard Deviation). Unit: pg/mL

Measure	Triptorelin Plus Tamoxifen n = 26	Triptorelin Plus Exemestane n = 83
Estradiol (E2) levels at baseline (0 months)	109.81 (119.151)	96.55 (151.235)
Estradiol (E2) levels at 3 months	4.876 (7.123)	3.973 (8.439)
Estradiol (E2) levels at 6 months	3.761 (2.02)	3.672 (8.006)
Estradiol (E2) levels at 12 months	4.013 (2.765)	2.486 (5)
Estradiol (E2) levels at 18 months	7.306 (16.325)	2.527 (6.204)
Estradiol (E2) levels at 24 months	4.453 (3.347)	2.52 (6.566)
Estradiol (E2) levels at 36 months	3.704 (2.138)	1.654 (2.764)
Estradiol (E2) levels at 48 months	5.914 (8.959)	9.073 (57.307)

Population analysed: The final (4 years) analysis cohort (N=109) consists of all patients from the intent to treat (ITT) population (N=123) who had at least 2 samples analyzed and who received at least one GnRH analogue triptorelin injection during follow-up. Fourteen patients were excluded due to the reasons of 1) never start TE and never received GnRH (gonadotropin-releasing hormone) analogue triptorelin; 2) only baseline sample available; 3) single sample at 24 months; 4) patients without sample analyzed.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Triptorelin Plus Exemestane n = 83
Patients with E2 > 2.72 pg/mL at baseline (0 months)	74
Patients with E2 > 2.72 pg/mL at 3 months	17
Patients with E2 > 2.72 pg/mL at 6 months	16
Patients with E2 > 2.72 pg/mL at 12 months	12
Patients with E2 > 2.72 pg/mL at 18 months	12
Patients with E2 > 2.72 pg/mL at 24 months	8
Patients with E2 > 2.72 pg/mL at 36 months	8
Patients with E2 > 2.72 pg/mL at 48 months	3

Population analysed: Among patients randomly assigned to exemestane + triptorelin and included in the analysis cohort (N=83), the number of patients who experienced suboptimal suppression at each timepoint, with 95% exact binomial confidence intervals (CI), were reported. Two patients were excluded due to no baseline sample.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Four years after randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triptorelin Plus Tamoxifen	0 of 0	0 of 0	0
Triptorelin Plus Exemestane	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prudence Francis, MD study chair

Peter MacCallum Cancer Centre, Australia

24 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing gas chromatography / tandem mass spectometry in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 24 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain, Switzerland, Italy, France, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.