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 ≤ 25 (OFSET)

Clinical Trial Details

NRG-BR009, also known as the “OFSET” trial, is a clinical study trying to determine whether the chance of breast cancer returning would be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian function suppression.

We are doing this study because we want to find out if adding chemotherapy will reduce the risk of the cancer returning for early-stage breast cancer that is sensitive to hormones and is HER2-negative.

The purpose of this study is to compare two commonly used treatment choices for early-stage breast cancer in premenopausal women. Patients with this type of breast cancer may receive chemotherapy as part of their usual care, but it is not clear with current information how much more benefit chemotherapy adds and if putting women into early menopause may give the same benefit as chemotherapy. The addition of chemotherapy to the other usual treatment could prevent the cancer from returning.

Participants will be randomized into one of two treatment groups. Group 1 receives ovarian suppression and hormonal therapy (the usual approach) and group 2 receives ovarian suppression and hormonal therapy plus chemotherapy.

All therapies given in this study are approved by the U.S. Food and Drug Administration.

Endocrine therapy includes a combination of a medication given via injection and an oral pill. Chemotherapy is most commonly administered intravenously (through an IV). The study team will discuss specific dosing regimens with each participant depending on the group they are assigned to.

Participants will come into the office for study visits every 3 months for the first two years of the study, with occasional visits occurring for up to 15 years. Other exams, tests, and procedures may be required to monitor health and safety, many of which are already included as part of usual care.

Key Eligibility:

Eligibility Criteria:
   1. Female patients must be over the age of 18
   2. Participants must be premenopausal women who have early-stage breast cancer that is sensitive to hormones and is HER2 negative, and an Oncotype DX Recurrence Score® equal to or less than 25.
   3. Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing
   mastectomy, or a lumpectomy.

Ineligibility Criteria:
   1. Patients having definitive clinical or radiologic evidence of metastatic disease.
   2. Patients with history of ipsilateral or contralateral invasive breast cancer.
   3. Hormonally based contraceptive measures must be discontinued prior to pre-entry
   (including progestin/progesterone IUDs).
   4. Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless
   the HBV viral load is undetectable on suppressive therapy. Patients with a history of
   hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured
   or have an undetectable HCV viral load if still on active therapy.

Detailed eligibility will be reviewed when you contact the study team.