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Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

NCT02712723

Active Not RecruitingPhase 2

Sponsor: Qamar Khan

Conditions: Breast Cancer

Interventions: Letrozole, Ribociclib, Placebo

Countries: United States

The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Pathologically confirmed invasive breast cancer by core needle biopsy
* Female subjects, age ≥ 18 years
* Only postmenopausal women will be eligible.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2
* Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8
* Invasive breast cancer must be HER2 negative.
* Clinical Stage II or III (by clinical measurement and/or breast imaging)

Key Exclusion Criteria:

* Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
* Current use of other investigational agents
* Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
* An excisional biopsy of this breast cancer
* Surgical axillary staging procedure prior to study entry
* Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
* Clinical or radiographic evidence of metastatic disease
* Clinically significant, uncontrolled heart disease
* Herbal preparations/medications as listed in Appendix B of the protocol
Locations (13)
  • Little Rock, Arkansas, United States
  • Duarte, California, United States
  • Santa Ana, California, United States
  • Deerfield Beach, Florida, United States
  • Kansas City, Kansas, United States
  • Overland Park, Kansas, United States
  • Westwood, Kansas, United States
  • Boston, Massachusetts, United States
  • Kansas City, Missouri, United States
  • Kansas City, Missouri, United States
  • Lee's Summit, Missouri, United States
  • New York, New York, United States
  • Madison, Wisconsin, United States