Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women

NCT ID: NCT01709370

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29

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)

Conditions

ER Positive, HER2 Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Letrozole, PD 0332991

Intervention Type: DRUG

Interventions

Letrozole, PD 0332991

Intervention Type: DRUG

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

• Male
• 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
• Poor adrenal function
• Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)
• Known human immunodeficiency virus infection
• Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor
• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organisation for Oncology and Translational Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unimed Medical Institute

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Louis Chow, MD

Role: CONTACT

Phone: (852)28610286

Facility Contacts

Louis Chow, MD

Role: primary

Other Identifiers

OOTR-N007/LET-CDK

Identifier Type: -

Identifier Source: org_study_id