Phase II Neoadjuvant Study of Letrozole in Combination With PD0332991 (Oral CDK 4/6 Inhibitor) for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women

Organisation for Oncology and Translational Research1 site in 1 country45 target enrollmentFebruary 2012

ConditionsER Positive, HER2 Negative Breast Cancer

InterventionsLetrozole, PD 0332991

DrugsLetrozole, PD 0332991

Overview

Phase: Phase 2
Intervention: Letrozole, PD 0332991
Conditions: ER Positive, HER2 Negative Breast Cancer
Sponsor: Organisation for Oncology and Translational Research
Enrollment: 45
Locations: 1
Primary Endpoint: Objective response rates
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Organisation for Oncology and Translational Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Postmenopausal women
•Primary tumor greater than 2 cm in diameter
•Histologically proven invasive breast cancer
•Positive estrogen receptor
•Negative HER-2 receptor
•ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%
•Laboratory values must be follows:
•Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470 msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction (LVEF) ≥ 60%.
•Able to give written informed consent form
•Able to follow prescription instructions reasonably well

Exclusion Criteria

•Severe psychiatric disorder
•Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix
•Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis
•Multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm
•Major surgery within 3 weeks of first study treatment
•Current use or anticipated need for:
•Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4 inducers
•Severe cardiovascular diseases in the previous 6 months
•Active inflammatory bowel disease or chronic diarrhea
•Renal Impairment

Arms & Interventions

Letrozole plus PD 0332991

Drug: Letrozole 2.5mg/d for 16 weeks before surgery plus PD 0332991 (CDK-4/6 inhibitor) 125 mg/d for 3 out of 4 weeks in repeated cycles for 16 weeks before surgery

Intervention: Letrozole, PD 0332991