A Phase II Study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2- Metastatic Breast Cancer - PYTHIA

ETOP IBCSG Partners Foundation0 sites120 target enrollmentSeptember 21, 2015

ConditionsPatients with endocrine-resistant metastatic or locally relapsed, ER+/HER2-negative breast cancer not amenable to treatment with a curative intent enrolled in the AURORA study.MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsIBRANCE

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with endocrine-resistant metastatic or locally relapsed, ER+/HER2-negative breast cancer not amenable to treatment with a curative intent enrolled in the AURORA study.
Sponsor: ETOP IBCSG Partners Foundation
Enrollment: 120
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 21, 2015

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

ETOP IBCSG Partners Foundation

Eligibility Criteria

Inclusion Criteria

•\- Histologically confirmed breast adenocarcinoma that is metastatic or locally relapsed disease not amenable to curative therapy.
•\- Female gender
•\- Age \= 18 years
•\-Postmenopausal, defined as women with:
•\- Prior bilateral surgical oophorectomy; or
•\- Amenorrhea and age \= 60 years; or
•\- Age \< 60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and serum estradiol levels within the laboratory’s reference ranges for postmenopausal women.
•\- Endocrine resistant disease, defined as one of:
•\- Relapse while on adjuvant endocrine therapy
•\- Relapse within 12 months after completion of adjuvant endocrine therapy

Exclusion Criteria

•\- Prior use of fulvestrant or any CDK inhibitor.
•\- More than one prior line of chemotherapy for metastatic or locally relapsed disease.
•\- Previous or current non\-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
•\- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy,) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before enrollment.
•\- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade \=2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification \=III, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
•\- QTc exceeding 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
•\- Uncontrolled electrolyte disorders that can reinforce the QT\-prolonging effect of the drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).
•\- Known history of HIV seropositivity. HIV screening is not required at baseline.
•\- Uncontrolled diabetes defined as HbA1c level \> 7\.5%.
•\- Concurrent disease or familial, sociological or geographical condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient’s safety.