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Hormone Therapy

Chemotherapy + Hormone Therapy 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

Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).

The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at one year after randomization

Awards & highlights

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

Who is the study for?

This trial is for premenopausal women at least 18 years old with early-stage, ER-positive/HER2-negative breast cancer and a low to intermediate recurrence score. They must have had surgery for breast cancer within the last 16 weeks and be eligible for radiation therapy. Women can't join if they are pregnant, breastfeeding, have severe heart issues, other non-breast cancers that could affect the study's safety or results, or any metastatic disease.Check my eligibility

What is being tested?

The trial is testing if adding adjuvant chemotherapy to ovarian function suppression plus endocrine therapy improves survival without invasive breast cancer returning in patients with certain types of early-stage breast cancer compared to just ovarian function suppression plus endocrine therapy.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, hair loss, fatigue and increased risk of infection; and from hormonal therapies like hot flashes, joint pain and bone thinning. The exact side effects will depend on the specific drugs used.

OFSET Trial Eligibility Criteria

Inclusion Criteria

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

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I have had a procedure to check for cancer in my underarm lymph nodes.

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My tumor is positive for estrogen or progesterone receptors.

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I am premenopausal with functioning ovaries.

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My tumor is not HER2 positive according to specific guidelines.

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I am a woman aged 18 or older.

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My surgery removed all visible cancer from the breast.

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My lumpectomy margins were clear of cancer and DCIS.

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I can take care of myself but might not be able to do heavy physical work.

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

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,922,481 Total Patients Enrolled

939 Trials studying Breast Cancer

1,539,400 Patients Enrolled for Breast Cancer

NRG OncologyLead Sponsor

231 Previous Clinical Trials

96,892 Total Patients Enrolled

8 Trials studying Breast Cancer

7,678 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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