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),
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.
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.
Parallel
Ribociclib 400mg
Drug400 mg (2 x 200 mg tablets by mouth) once daily on days 1 to 21 of a 28-day cycle, followed by seven days off ribociclib (Days 22 to 28).
Letrozole 2.5mg
DrugLetrozole will be administered as an endocrine therapy. The regimen will differ depending on the demographic of the patient. For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously.
Anastrazole 1mg
DrugFor postmenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.
Goserelin 3.6 MG
DrugFor men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, concurrently with goserelin 3.6 mg monthly injection.
Adjuvant chemotherapy
RadiationAdjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.
Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
Discontinuation rate of ribociclib in participants with resected 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), ER-positive, HER2-negative breast cancer who choose to forgo adjuvant chemotherapy in their treatment regimen. One-year treatment discontinuation is defined as treatment discontinuation within one year for any reason (e.g., adverse events, disease recurrence, patient/investigator decision, lost to follow up, etc).
Invasive disease-free survival in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
iDFS is defined as the time from initiation of treatment to the first diagnosis of local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause prior to recurrence or second primary cancer using STEEP criteria as assessed by investigator. iDFS using STEEP criteria, assessed separately in the participants who select to omit adjuvant chemotherapy (arm 1) and those who include adjuvant chemotherapy in their treatment regimen (arm 2).
Change from Baseline in Severity of Symptoms in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
This seeks to assess the change from baseline in the severity of symptoms. This will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G) GP5. FACT-G GP5 will be scored from scale of 0-4; with 0 indicating "not at all" and 4 indicating "very much". The objective is to describe patient-reported outcomes (PRO) for these measures in participants in arm 1 and arm 2.
Change from Baseline in Physical Functioning and Global Health Status/Quality of Life in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
This seeks to evaluate the change from baseline in the physical functioning sub-scale score and global health status/Quality of Life scale score of participants. This will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This questionnaire is scored from 1 to 4; with 1 indicating 'not at all' and 4 indicating 'very much'. The objective is to describe patient-reported outcomes related to health-related quality-of-life in participants in arm 1 and arm 2.
Factors Impacting Decision Making in Adjuvant Treatment Decisions in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
This seeks to to identify and understand the factors that impact participants' decision-making processes, as assessed by a modified version of the Control Preferences Scale. This tool uses a card-sorting method, where participants are asked to rank five cards with different decision-making roles. It is then scored by the participant's preference order over the five cards. The objective is to explore the factors influencing the decision to include or omit adjuvant treatment among participants in arm 1 and arm 2. This assessment will help in understanding the preferences and considerations of patients regarding their treatment plans.
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