Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

This is a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25),

Eligibility criteria

Qualifiers

Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document.

Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.

Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.

Participants underwent a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.

Disqualifiers

Definitive clinical or radiologic evidence of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.

T4 tumors, including inflammatory breast cancer.

N3 tumors.

Participants that have received neoadjuvant chemotherapy or biotherapy.

Trial design

Treatments tested in this trial

  • Ribociclib 400mg
  • Letrozole 2.5mg
  • Anastrazole 1mg
  • Goserelin 3.6 MG
  • Adjuvant chemotherapy

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

Novartis

Collaborator

Breast Cancer Research Foundation

Collaborator