EUCTR2014-005387-15-IT
Active, not recruiting
Phase 1
A Phase II Study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2- Metastatic BreastCancer - PYTHIA
INTERNATIONAL BREAST CANCER STUDY GROUP0 sites120 target enrollmentJune 17, 2021
ConditionsPatients with endocrine-resistant metastatic or locally relapsed breast cancer not amenable to treatment with a curative intent ER+/HER2-, enrolled in the AURORA studyMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with endocrine-resistant metastatic or locally relapsed breast cancer not amenable to treatment with a curative intent ER+/HER2-, enrolled in the AURORA study
- Sponsor
- INTERNATIONAL BREAST CANCER STUDY GROUP
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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 greater or equal to 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).
Outcomes
Primary Outcomes
Not specified
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