West Cancer Center

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)

Title

NRG Breast adjuvant ER+ low oncotype

Study Title

Site Link

NCT05879926

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

Greg Vidal, MD, PhD

Sponsor

NRG Oncology

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes