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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
ER Positive, HER2 Negative Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rates

Safety Issue:

No

Authority:

Hong Kong: Department of Health

Study ID:

OOTR-N007/LET-CDK

NCT ID:

NCT01709370

Start Date:

February 2012

Completion Date:

Related Keywords:

  • ER Positive, HER2 Negative Breast Cancer
  • Breast Neoplasms

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