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

Primary Purpose

ER Positive, HER2 Negative Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Letrozole, PD 0332991

About this trial

This is an interventional treatment trial for ER Positive, HER2 Negative Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Unimed Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Letrozole plus PD 0332991

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rates

Secondary Outcome Measures

Number of Participants with Adverse Events

Full Information

NCT ID

NCT01709370

First Posted

October 15, 2012

Last Updated

December 29, 2013

Sponsor

Organisation for Oncology and Translational Research

1. Study Identification

Unique Protocol Identification Number

NCT01709370

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organisation for Oncology and Translational Research

4. Oversight

Data Monitoring Committee

Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ER Positive, HER2 Negative Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Letrozole plus PD 0332991

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Letrozole, PD 0332991

Primary Outcome Measure Information:

Title

Objective response rates

Time Frame

Every 4 weeks before surgery

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Pathologic response rates

Time Frame

At time of definitive surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Louis Chow, MD

Phone

(852)28610286

Facility Information:

Facility Name

Unimed Medical Institute

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louis Chow, MD

Phone

(852)28610286

First Name & Middle Initial & Last Name & Degree

Louis Chow, MD

12. IPD Sharing Statement

Learn more about this trial

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

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