SHS_492363 ELLE CABP 16229

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.

Select Inclusion Criteria:

Postmenopausal women age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry or age greater than or equal to 18 with documented bilateral oophorectomy.
Operable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment.
No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments.
A breast tumor with an ultrasound size of at least 2.0 cm.
Ability to swallow oral medication.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet various criteria (see protocol).

Exclusion Criteria:

Active hepatitis B or hepatitis C with abnormal liver function tests.
HIV positive patients receiving antivirals.
Premenopausal or peri-menopausal women.
Inflammatory/inoperable breast cancer.
HER2-positive as determined using ASCO-CAP Guidelines.
Concurrent use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)
Prior endocrine therapy for breast cancer.
Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).
Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.
Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).
Definitive clinical or radiologic evidence of metastatic disease.
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or contralateral invasive breast cancer at any time.
Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes.
Class III or Class IV myocardial disease.
Phase II
Erin Ellis, M.D.
NSABP (National Surgical Adjuvant Breast and Bowel Project)
Alana Brooks
  • Swedish Medical Center