Clinical trial NCT02025712: Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer
Official title: A Phase II Open-label Pilot Study Evaluating the Maintenance Therapy With Exemestane Plus Everolimus After Induction Chemotherapy in Patients With Hormone-receptor Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast
Lead sponsor: Organisation for Oncology and Translational Research
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.

Detailed description: Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women as defined in the protocol page 9;
* Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
* Confirmed ER/PR-positive, and HER-2 negative tumor;
* Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
* Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
* ECOG performance status ≤ 2 or Karnofsky performance status ≥ 50% prior to the start of study treatment;
* Adequate organ function prior to the start of study treatment as defined in the protocol;
* Able to swallow and retain oral medication;
* Able to give written informed consent;

Exclusion Criteria:

* Male patient;
* Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
* History of brain or other CNS metastases;
* Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped \>1 year before metastatic relapse;
* Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
* History of neurological or psychiatric disorders;
* Any serious cardiovascular diseases in the previous 6 months;
* Impairment of gastrointestinal function or gastrointestinal disease;
* Patients with uncontrolled infection;
* Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day);
* Chronic treatment with systemic steroids or another immunosuppressive agent;
* Patients with a pre-existing peripheral neuropathy \> grade 1;
* Patients who are hepatitis B and/or hepatitis C carriers;
* Known human immunodeficiency virus infection;
* Prior exposure to mTOR inhibitors;
* Hypersensitivity to rapamycin or other similar compounds;
* Patients taking medications known to be inhibitors or inducers of CYP3A4 and/or PgP will not be included in this study;
* Prior treatment with any investigational agent within the preceding 4 weeks;
* Other conditions in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
Secondary outcomes:
measure: Response rate
timeFrame: Every 8 weeks, up to 8 months (estimated)
measure: Clinical benefit rate
timeFrame: Every 8 weeks, up to 8 months (estimated)
measure: Overall survival
timeFrame: date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
measure: Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
timeFrame: Continuous during the study, up to 28 days after the last treatment
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Unimed Medical Institute
Study officials:
affiliation: Organisation for Oncology and Translational Research
name: Louis Chow
role: PRINCIPAL_INVESTIGATOR
References: