Phase III study of Palbociclib (PD-0332991) in combination with Endocrine therapy (exemestano or fulvestrant) versus chemotherapy (capecitabine) in Hormonal Receptor (HR) positive/HER2 negative Metastatic Breast Cancer (MBC) patients with Resistance to non-steroidal Aromatase inhibitors (The PEARL study) - PEAR

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 sites550 target enrollmentAugust 9, 2016

ConditionsPatients with hormonal receptor positive and HER2 negative MBC who are resistant to prior NSAI therapy.MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsAromasin Faslodex

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with hormonal receptor positive and HER2 negative MBC who are resistant to prior NSAI therapy.
Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
Enrollment: 550
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 9, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

Eligibility Criteria

Inclusion Criteria

•1\.The patient has signed the informed consent document.
•2\.Females with histologically confirmed MBC whose disease is resistant to previous non\-steroidal aromatase inhibitors (letrozole or anastrozole), defined as:
•\- Recurrence while on or within 12 months after the end of adjuvant treatment with NSAI or
•\- Progression while on or within 1 month after the end of treatment with NSAI for advanced disease.
•3\.Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or first line therapy for MBC.
•4\.It is not mandatory to have letrozole or anastrozole as the most recent treatment before randomization but progression of the MBC documented during receipt of the most recent systemic therapy before randomization should be documented.
•5\.Hormonal receptor positive (HR\+) breast cancer based on local laboratory determination. HR\+ defined as \> or \= 1% positive cells by IHC for ER and/or PgR.
•6\.Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy. HER2 negative tumor is determined according to the most current recommendations of ASCO/CAP guidelines (2013\), as IHC score 0 or 1\+ or negative by ISH (FISH/CISH/SISH) defined as a HER2/CEP17 ratio \< 2 with an average HER2 copy number \<4\.0, or for single probe assessment a HER2 copy number \< 4\.
•7\.Measurable disease or at least one bone lesion, lytic or mixed (lytic\+blastic), which has not been previously irradiated and is assessable by CT/MRI in the absence of measurable disease according to RECIST 1\.1 criteria.
•8\.Patient is at least 18 years of age.

Exclusion Criteria

•1\. Have received more than 1 prior chemotherapy regimen for MBC. NOTE: Other previous anticancer endocrine treatments for advanced disease are allowed.
•2\. Patients with advanced, symptomatic, visceral spread that are at risk of life\-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, peritoneal], pulmonary lymphangitis and over 50% liver involvement).
•3\. 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 (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
•4\. Prior treatment with any CDK4/6, mTOR or PI3K inhibitor \[any agent whose mechanism of action is to inhibit the PI3 kinase\-mTOR pathway] or capecitabine.
•a) Patients included in Cohort 1: Prior treatment with exemestane in the metastatic setting. If the patient has received exemestane in the adjuvant setting and developed MBC, she will be eligible for the study provided: \- She has received letrozole/anastrozole as first\-line MBC and progressed. \- At least 1 year has elapsed since the end of adjuvant exemestane treatment. b) Patients included in Cohort 2: Prior treatment with fulvestrant in the metastatic setting. If the patient has received fulvestrant in the adjuvant setting and developed MBC, she will be eligible for the study provided: \- She has received letrozole/anastrozole as first\-line MBC and progressed. \- At least 1 year has elapsed since the end of adjuvant fulvestrant treatment.
•6\. Patients treated within the last 7 days prior to randomization with:
•\- Food or drugs that are known to be CYP3A4 inhibitors
•\- Drugs that are known to be CYP3A4 inducers
•\- Drugs that are known to prolong the QT interval
•7\. Major surgery, chemotherapy, radiotherapy, any investigational agent or other anti\-cancer therapy within 4 weeks before randomization. Patients who received prior radiotherapy to \> or \= 25% of bone marrow are not eligible independent of when it was received.