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Hormone Therapy

Ovarian Function Suppression + Aromatase Inhibitor for Breast Cancer(OFSET Trial)

Phase 3

Recruiting

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The tumor must be ER and/or PgR-positive by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.

For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS are eligible without additional resection.)

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Uptime from randomization for duration of trial, 11 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

OFSET Trial Summary

This trial will test if adding chemotherapy to hormones improves the likelihood of survival from early stage ER+ breast cancer. #breastcancer #chemotherapy #hormones

Eligible Conditions

Breast Cancer

OFSET Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You can participate in the study if you have breast cancer in both breasts, as long as the main tumor meets the requirements for the study and the other areas of cancer don't need chemotherapy or HER2-targeted treatment.

OFSET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization for duration of trial, 11 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization for duration of trial, 11 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization for duration of trial, 11 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Invasive breast cancer-free survival (IBCFS)

Secondary outcome measures

Breast cancer-free interval (BCFI)

Distant recurrence-free interval (DRFI)

Invasive disease-free survival (IDFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

OFSET Trial Design

2Treatment groups

Active Control

Group I: Arm 1: Ovarian Function Suppression + Aromatase InhibitorActive Control1 Intervention

Aromatase inhibitor co-administered with a GnRH agonist (gonadotropin releasing hormone) for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.

Group II: Arm 2 Adjuvant Chemotherapy + Ovarian Function Suppression + Aromatase InhibitorActive Control2 Interventions

Adjuvant chemotherapy of investigator's choice followed by an aromatase inhibitor (AI) co-administered with an GnRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

226 Previous Clinical Trials

95,824 Total Patients Enrolled

8 Trials studying Breast Cancer

7,678 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,489 Previous Clinical Trials

41,262,717 Total Patients Enrolled

933 Trials studying Breast Cancer

1,536,767 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Arm 1: Ovarian Function Suppression + Aromatase Inhibitor?

"Our internal analysis at Power scored Arm 1: Ovarian Function Suppression + Aromatase Inhibitor with a 3 due to the Phase 3 clinical trial that provided evidence of its efficacy and safety."

Answered by AI

What is the current total of participants in this research project?

"That is correct. Clinicaltrials.gov states that this research project, which was first available on August 31st 2023, is currently recruiting participants from one site in need of 3960 volunteers."

Answered by AI

Can individuals below the age of 45 partake in this research project?

"As stipulated in the study's conditions, only individuals aged 18-60 may take part."

Answered by AI

Am I able to register for participation in this clinical study?

"To be eligible for the study, candidates must have a diagnosis of breast cancer and fall between 18 to 60 years old. The research team is aiming to recruit 3960 volunteers in total."

Answered by AI

Is the call for participants still open on this particular clinical trial?

"Affirmative. As indicated by the data available on clinicaltrials.gov, this medical research study is currently recruiting subjects and was most recently updated in August of 2023. The trial requires 3960 patients to be recruited from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

2023. "Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05879926.

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