Breast CancerOpen to EnrollmentPhase 3

BREAST: ADJUVANT: ER+:HER2-:PREMENOPAUSAL: ONCOTYPE <25: OFSET

A Phase III Adjuvant Trial 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 (OFSET)

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Study snapshot

Title: NRG Breast adjuvant ER+ low oncotype
Malignancy: Breast cancer, ER positive breast cancer
Stage: Stage 2
Disease setting: Adjuvant/Post-surgical
Line of therapy: Adjuvant
Investigational agent: chemotherapy, ovarian suppression, and endocrine therapy
Drug class: chemotherapy, ovarian suppression, and endocrine therapy
Principal investigator: Greg Vidal, MD, PhD
Sponsor: NRG Oncology
Path: adenocarcinoma
Randomized: Yes
ClinicalTrials.gov ID: NCT05879926

Eligibility and objectives

Key eligibility criteria details

Premenopausal
- Age 40 years or under with spontaneous menses within 12 months
- Age 50-60 years with spontaneous menses within 12 months plus FSH and estrodiol measurements within premenopausal range
- Amenorrhea due to IUD or uterine ablation or hysterectomy must have FSH and estrodiol ranges in premenopausal range
ECOG PS 0-2
Multicentric or multifocal breast cancer is allowed
Must have had definitive breast surgery (+radiation if indicated)
Primary tumor must be T1-3
Nodes must be N0 or N1
Oncotype score must be,
- if node negative: 21-25 or high clinical risk (with oncotype 16-20)
- If 1-3 nodes, must be <26
Must be ER/PR positive
Must be HER2 negative
No metastatic disease

Objective

Primary
- Invasive breast cancer free survival
Secondary
- IDFS
- OS
- Distant recurrence free survival
- breast cancer-free interval
- QOL
- Pain

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details