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

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01233947

Enrollment

Registered

2010-11-03

Start date

2011-05-31

Completion date

2012-08-31

Last updated

2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Brief summary

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.

Detailed description

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.

Interventions

DRUGAFP464

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

DRUGAFP464 + 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

* HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,

Design outcomes

Primary

Measure	Time frame	Description
Clinical Benefit Response	6 months	Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.

Secondary

Measure	Time frame	Description
Progression Free Survival	6 months	Determination of progression free survival
Number of participants with adverse events	6 months	Determination of the number of patients who experience adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026