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A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy

To study the effect of adding chemotherapy given after breast surgery with aromatase inhibitor and ovarian suppression versus ovarian suppression and endocrine therapy alone, in premenopausal patients with ER-positive, HER2-negative breast cancer.

Age & Gender

18 years ~ 99 years
Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

If you take part in the study, you will be randomized to one of the two groups: Group 1- ovarian suppression drug with hormonal therapy; or Group 2-chemotherapy and then an ovarian suppression drug with hormonal therapy for up to 5 years. You or the doctor will not be able to determine which group you will be in. After the treatment is completed, the study team will check you annually for 15 years after you joined the study. There will be blood samples and optional sample collections for the study.

In-person visits:
5-10

Total length of participation:
15 years

Looking for Specific Volunteers

Able to participate:

You are premenopausal.
You have had surgery for your breast cancer within 16 weeks of study entry.
You have been told your breast tumor is ER and/or PgR-positive.
You have been told your tumor is HER2-negative.

Not eligible if:

Your breast cancer is metastatic.
You are currently taking hormonally based contraception.
You have a history of or currently have symptoms of heart disease.
You have previously received radiation, chemotherapy or biotherapy for your current breast cancer.
You are currently pregnant or breastfeeding.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Claire Dees
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-3116

ClinicalTrials.gov

NCT05879926

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