Clinical trial NCT01709370: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: ER Positive, HER2 Negative Breast Cancer
Lead sponsor: Organisation for Oncology and Translational Research
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Objective response rates
timeFrame: Every 4 weeks before surgery
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Continuous during the study, up to 28 days after the last treatment
Other outcomes:
measure: Pathologic response rates
timeFrame: At time of definitive surgery
Locations:
city: Hong Kong
country: China
facility: Unimed Medical Institute
Study officials:
References: