Study of AFP464 +/- Faslodex in ER + Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors

NCT05262400

Breast Cancer Solid Tumors

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)

NCT01791985

Breast Cancer

COMPLETED PHASE1/PHASE2

Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI

NCT01797120

Metastatic Breast Cancer

COMPLETED PHASE2

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

NCT02540330

Female Breast Carcinoma Female Ductal Carcinoma In Situ

TERMINATED PHASE2

Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

NCT03624478

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 +5 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AFP464

74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.

Group Type EXPERIMENTAL

AFP464

Intervention Type DRUG

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle

AFP464 + Faslodex

AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.

Group Type EXPERIMENTAL

AFP464 + Faslodex

Intervention Type DRUG

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AFP464

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle

Intervention Type DRUG

AFP464 + Faslodex

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

(aminoflavone) (aminoflavone) + (Fulvestrant)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29\>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.