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Trial Title:
Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
NCT ID:
NCT01709370
Condition:
ER Positive, HER2 Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Palbociclib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Letrozole, PD 0332991
Arm group label:
Letrozole plus PD 0332991
Summary:
This is a phase II study evaluating the efficacy and safety of the pre-operative use of
letrozole plus PD 0332991 (combination therapy)
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Unimed Medical Institute
Address:
City:
Hong Kong
Country:
China
Status:
Recruiting
Contact:
Last name:
Louis Chow, MD
Phone:
(852)28610286
Investigator:
Last name:
Louis Chow, MD
Email:
Principal Investigator
Start date:
February 2012
Lead sponsor:
Agency:
Organisation for Oncology and Translational Research
Agency class:
Other
Source:
Organisation for Oncology and Translational Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01709370