Conditions: Breast Cancer
Keywords: Metastatic breast cancer Invasive breast carcinoma estrogen receptor-positive breast cancer HER2-negative breast cancer Stage IV breast cancer progesterone receptor-positive breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus fulvestrant alone.

Detailed description:
OBJECTIVES:

Primary

* To test the benefit of interfering with the function of the estrogen receptor (ER) and providing downstream target inhibition (PI3K/AKT/mTOR) with a combination of optimal dose fulvestrant and everolimus (Arm 2) to improve progression-free survival compared to the optimal dose fulvestrant alone (Arm 1).
* To test the benefit of adding the non-steroidal aromatase inhibitor anastrozole to optimal dose fulvestrant and everolimus (Arm 3) in order to improve progression free survival over optimal dose fulvestrant (Arm 1).

Secondary

* To compare progression-free survival among those receiving fulvestrant + everolimus + anastrozole (Arm 3) versus fulvestrant + everolimus (Arm 2).
* To compare overall survival among the treatment arms in post-menopausal patients with hormone-receptor positive (HR+) Stage IV breast cancer.
* To assess and compare toxicities, feasibility and compliance among the study regimens.
* To compare response rates and clinical benefit rates among the study regimens.
* To test molecular determinants of response to endocrine therapy and everolimus in circulating tumor cells:

  1. CTC-Endocrine Therapy Index (CTC ETI) on the CellSearch® platform.
  2. CTC-Next Generation Sequencing Analysis (CTC-NGS) of single cells captured on the HD-CTC® platform.

OUTLINE:

This is a multicenter study. Patients will be stratified according to the following factors:

* Measurable versus evaluable non-measurable disease
* Prior adjuvant hormonal therapy completed more than 5 years ago vs. prior adjuvant hormonal therapy completed 1-5 years ago vs. de novo presentation of metastatic disease or no prior adjuvant hormonal therapy.

ARMS:

* Arm 1: fulvestrant + placebo (everolimus) + placebo (anastrozole)
* Arm 2: fulvestrant + everolimus + placebo (anastrozole)
* Arm 3: fulvestrant + everolimus + anastrozole

Blood and tissue samples are collected for correlative science studies.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 5 years.

Arms:
arm 1: Patients receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. arm 2: Patients receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. arm 3: Patients receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.

Interventions: intervention 1: Fulvestrant intervention 2: Anastrozole intervention 3: Everolimus intervention 4: Placebo - Anastrozole intervention 5: Placebo - Everolimus
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol document:
Prot_SAP_ICF_000.pdf: 
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