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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Organisation for Oncology and Translational Research
Sponsor:
Information provided by (Responsible Party):
Organisation for Oncology and Translational Research
ClinicalTrials.gov Identifier:
NCT01709370
First received: October 15, 2012
Last updated: December 29, 2013
Last verified: October 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Organisation for Oncology and Translational Research:

Primary Outcome Measures:
  • Objective response rates [ Time Frame: Every 4 weeks before surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Continuous during the study, up to 28 days after the last treatment ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Pathologic response rates [ Time Frame: At time of definitive surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2012
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709370

Contacts
Contact: Louis Chow, MD (852)28610286

Locations
China
Unimed Medical Institute Recruiting
Hong Kong, China
Contact: Louis Chow, MD    (852)28610286      
Principal Investigator: Louis Chow, MD         
Sponsors and Collaborators
Organisation for Oncology and Translational Research
  More Information

No publications provided

Responsible Party: Organisation for Oncology and Translational Research
ClinicalTrials.gov Identifier: NCT01709370     History of Changes
Other Study ID Numbers: OOTR-N007/LET-CDK
Study First Received: October 15, 2012
Last Updated: December 29, 2013
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014