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

Sponsor

Organisation for Oncology and Translational Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT01709370

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
ER Positive, HER2 Negative Breast Cancer	Drug: Letrozole, PD 0332991	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Letrozole, PD 0332991

Arm

Intervention/Treatment

Experimental: 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

Drug: Letrozole, PD 0332991

Outcome Measures

Primary Outcome Measures

Objective response rates [Every 4 weeks before surgery]

Secondary Outcome Measures

Number of Participants with Adverse Events [Continuous during the study, up to 28 days after the last treatment]

Other Outcome Measures

Pathologic response rates [At time of definitive surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unimed Medical Institute	Hong Kong		China

Sponsors and Collaborators

Organisation for Oncology and Translational Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organisation for Oncology and Translational Research

ClinicalTrials.gov Identifier:

NCT01709370

Other Study ID Numbers:

OOTR-N007/LET-CDK

First Posted:

Oct 18, 2012

Last Update Posted:

Dec 31, 2013

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Breast Neoplasms

Letrozole

Palbociclib

Study Results

No Results Posted as of Dec 31, 2013