Exemestane and Cyclophosphamide for Metastatic Breast Cancer

NCT01963481 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 13-00761
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.

Conditions

Metastatic Beast Cancer

Keywords

hormonal therapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Rate at 3 Months

  PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study. The percent of participants with PFS at 3 months will be reported.

  3 months

Secondary Outcomes (2)

• Response Rate (RR) - Complete Response and Partial Response

  2 years

• Clinical Benefit Rate Score

  3 years

Study Arms (1)

Exemestane and cyclophosphamide

EXPERIMENTAL

A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.

Drug: Exemestane; Drug: Cyclophosphamide

Interventions

Exemestane DRUG

Also known as: Aromasin

Exemestane and cyclophosphamide

Cyclophosphamide DRUG

Also known as: Cytoxan, CTX

Exemestane and cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed breast cancer that is ER positive and/or PR positive, and HER2/neu negative and have disease that is metastatic (stage IV)
• HER2/neu negative disease determined using commercially available/approved assay in local institutional or reference laboratory, according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (IHC 0-1+ or 2+ with HER2/17 ratio on FISH \<= 1.8).
• ER/PR expression performed by standard immunohistochemical assay and classified as ER and/or PR-positive according to ASCO/CAP guidelines (1-100% expression)
• Histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, furthermore, if feasible, the biopsy should confirm that the metastatic tumor is ER and/or PR positive and HER2/neu negative. For patients in whom histologic biopsy confirmation and/or assessment of ER/PR/HER2 of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negative.
• Measurable disease (RECIST 1.1) or non-measurable (assessable) disease
• Patients must have had progressive disease during at least one line of endocrine therapy for metastatic disease or have recurrent disease while or within 12 months of receiving adjuvant endocrine therapy. Prior treatments accepted include a non-steroidal aromatase inhibitor, tamoxifen, fulvestrant or combinations.
• Patients taking bisphosphonates for bone disease are permitted to enter the trial, but their bone lesions are not considered to be assessable for response, although they are assessable for progression.
• Female or male subjects age \>= 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count \>= 1,200/mcL
• platelets \>= 100,000/mcL
• hemoglobin \>= 9g/dl
• total bilirubin \<= 2 X upper limit of normal (ULN) \[unless due to Gilbert's disease\]
• AST(SGOT) \<= 2.5 X ULN

You may not qualify if:

• Patients may not be receiving any other investigational agents.
• Prior treatment for breast cancer with a steroidal aromatase inhibitor; with the exception of patients who were started on the combination of exemestane with everolimus less than 4 weeks prior to study entry and discontinued everolimus due to poor tolerability.
• Presence of life threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread) or uncontrolled brain metastases.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Kwa M, Li X, Novik Y, Oratz R, Jhaveri K, Wu J, Gu P, Meyers M, Muggia F, Speyer J, Iwano A, Bonakdar M, Kozhaya L, Tavukcuoglu E, Budan B, Raad R, Goldberg JD, Unutmaz D, Adams S. Serial immunological parameters in a phase II trial of exemestane and low-dose oral cyclophosphamide in advanced hormone receptor-positive breast cancer. Breast Cancer Res Treat. 2018 Feb;168(1):57-67. doi: 10.1007/s10549-017-4570-4. Epub 2017 Nov 9.

  PMID: 29124456 DERIVED

MeSH Terms

Interventions

exemestane; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Sylvia Adams
• Organization: NYU Langone Health

Sylvia.Adams@nyulangone.org

212 731 5795

Study Officials

• Sylvia Adams, MD

  NYU Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 16, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Locations

US (1)