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Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

NCT03377101 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-14

No results posted yet for this study

Summary

This randomized phase II trial studies the side effects and how well fulvestrant and palbociclib with or without copanlisib work in treating patients with hormone receptor positive, HER2 negative, stage IV breast cancer. Fulvestrant, palbociclib, and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Progesterone Receptor Positive
  • Stage IV Breast Cancer AJCC v6 and v7

Interventions

DRUG

Copanlisib

Given IV

DRUG

Fulvestrant

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Palbociclib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Cynthia Ma · Duke University - Duke Cancer Institute LAO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2018-08-07
Completion
2018-08-07
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03377101 on ClinicalTrials.gov