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

NCT01709370 | Unknown Phase 2 DMC

• 1 other identifier: OOTR-N007/LET-CDK
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective response rates

  Every 4 weeks before surgery

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  Continuous during the study, up to 28 days after the last treatment

Other Outcomes (1)

• Pathologic response rates

  At time of definitive surgery

Study Arms (1)

Letrozole plus PD 0332991

EXPERIMENTAL

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

Drug: Letrozole, PD 0332991

Interventions

Letrozole, PD 0332991 DRUG

Letrozole plus PD 0332991

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organisation for Oncology and Translational Research: lead

Study Sites (1)

Unimed Medical Institute

Hong Kong, China

RECRUITING

MeSH Terms

Interventions

Letrozole; palbociclib

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Louis Chow, MD

CONTACT

(852)28610286

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 18, 2012
• Study Start: February 1, 2012
• Last Updated: December 31, 2013

Record last verified: 2012-10

Locations

CN (1)