Assessment of HER status in patients with breast cancer should follow the  American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria () as practicable.
Cohort A Dose Escalation (Ribociclib + PDR): Breast participants:\r\n* Hormone receptor (HR)-positive, HER-negative metastatic breast cancer according to American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\r\n* Men are eligible, as long as on a gonadotropin releasing hormone (GNRH) agonist for at least  weeks prior to study entry; men MUST remain on the GnRH agonist for the duration of protocol\r\n* Prior Chemotherapy: Participants may have received any number of prior lines of chemotherapy for advanced breast cancer, as long as the last dose is >=  days prior to first dose of study treatment.
Histological confirmation of HER-positive advanced breast cancer; HER+ is defined by  American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
The primary tumor, and/or metastasis must have been tested for ER, PR and HER , and be HER positive as defined by the  American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
Participant has human epidermal growth factor receptor  (HER) negative breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists guidelines.
Histologically confirmed HR+/HER- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
Subjects who enroll in the triple-negative breast cancer (TNBC) dose expansion cohort should adhere to the American Society for Clinical Pathology (ASCP)/College of American Pathologists (CAP) guidelines for the definition of TNBC.
Breast cancer determined to be HER-negative per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER Guidelines\r\n* Note: Eligibility should be based on the HER status reported at the time of the most recent biopsy or resection
Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA/College of American Pathologists (CAP) or equivalent laboratory certification
Breast cancer must be determined by local testing to be human epidermal growth factor receptor  (HER)-positive prior to study entry using American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) HER test guidelines.
Has documented HER negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines
No evidence of ischemic heart disease based on  American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
Must be HER-positive in primary breast tumor or lymph node by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 
Histologically confirmed breast cancer that overexpresses HER (defined by American Society of Clinical Oncology [ASCO]- College of American Pathologists [CAP]  guidelines performed using Food and Drug Administration [FDA]-approved tests by laboratories with demonstrated proficiency) that is metastatic or unresectable
HER/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or equivalent laboratory certification
Human epidermal growth factor receptor  (HER) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.
Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or equivalent laboratory certification
Newly diagnosed (cohort ) stage IV metastatic ER+HER- breast cancer histologically proven per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; allow up to  days prior use of endocrine therapy +/- CDK/ inhibitors for treatment of metastatic ER+ breast cancer
HER positivity as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Patients who are Human epidermal growth factor  +(HER+) as defined by American Society of Clinical Oncology and College of American Pathologists (ASCO CAP) guidelines must have failed all prior therapy known to confer clinical benefit
Operable ER-positive/HER- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment. HER-negative as determined by American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines.
Participants must have documented HER+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology  College of American Pathologists)  guidelines; central confirmation of HER status is not required
Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Assessment of HER status in subjects with breast cancer should follow the  American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria (Wolff et al, ) as practicable.
High-risk patients (as defined by the American College of Sports Medicine risk-stratification schema using the American College of Sports Medicine [ACSM]/American Heart Association exercise pre-participation questionnaire) who do not receive medical clearance from a physician
Human epidermal growth factor receptor-  (HER- ) negativity will be based on the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines for HER testing
Up to date with all age appropriate cancer screening tests, as per American Cancer Society guidelines
HER negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER status.
Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.