- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963481
Exemestane and Cyclophosphamide for Metastatic Breast Cancer
March 3, 2020 updated by: NYU Langone Health
Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Estrogen can cause the growth of breast cancer cells.
Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.
Low dose cyclophosphamide may also stimulate the white blood cells, including natural killer cells, for instance by decreasing the suppressor (regulatory) T-cells.
Giving exemestane with cyclophosphamide may be an effective treatment for estrogen receptor-positive, progesterone receptor-positive, and HER2-negative stage IV breast cancer.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- ALT(SGPT) <= 2.5 X ULN
- creatinine <= 1.5 X ULN
- Patients must be able to swallow and tolerate oral medications.
- Postmenopausal status, defined as 60 years and older, being 45 years and older and having amenorrhea x 12 months or follicle stimulating hormone levels within postmenopausal range, OR having undergone a bilateral oophorectomy.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exemestane and cyclophosphamide
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. |
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) Rate at 3 Months
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (RR) - Complete Response and Partial Response
Time Frame: 2 years
|
Complete response (CR) is defined as the disappearance of all target lesions, while partial response (PR) is when at least a 30% decrease in the sum of the diameters of target lesions.
Evaluation of response is based on RESIST guideline version 1.1.
RR is reported as percentage of participants with a CR and/or PR at 2 years.
|
2 years
|
Clinical Benefit Rate Score
Time Frame: 3 years
|
Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks.
Evaluation of response and disease progression is based on RESIST guideline version 1.1.
Response and progression are assessed every 12 weeks.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sylvia Adams, MD, NYU Perlmutter Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
October 11, 2013
First Submitted That Met QC Criteria
October 11, 2013
First Posted (Estimate)
October 16, 2013
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 3, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Cyclophosphamide
- Exemestane
Other Study ID Numbers
- 13-00761
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Beast Cancer
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedGIST Metastatic Cancer | Breast Metastatic Cancer | Kidney Metastatic Cancer | Colon Metastatic Cancer | Rectal Metastatic CancerFrance
-
Orion Biotechnology Polska Sp. z o.o.Not yet recruitingMetastatic Colorectal Cancer | Metastatic Cancer | Metastatic Breast Cancer | Metastatic Urothelial Carcinoma | Metastatic Gastric Cancer | Metastatic Pancreatic Cancer
-
Institut de Cancérologie de la LoireSaint-Louis Hospital, Paris, France; Gustave Roussy, Cancer Campus, Grand ParisWithdrawnMetastatic Colorectal Cancer | Metastatic Breast Cancer | Metastatic Head and Neck CancerFrance
-
Gottfried MayaUnknownMetastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Prostate Cancer | Metastatic Gastric Cancer | Metastatic Bladder CancerIsrael
-
Albert Einstein College of MedicineTerminatedCancer | Solid Tumor | Metastatic Solid Tumor | Metastatic dMMR Solid CancerUnited States
-
Advaxis, Inc.TerminatedMetastatic Melanoma | Urothelial Carcinoma | Metastatic Non-Small Cell Lung Cancer | Head and Neck Cancer Metastatic | Colon Cancer MetastaticUnited States
-
Cedars-Sinai Medical CenterRecruitingNeoplasms | Cancer | Cancer, MetastaticUnited States
-
Cota Inc.Blue Cross Blue Shield; NantHealth Inc.TerminatedPancreatic Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Melanoma | Metastatic Prostate Cancer | Metastatic Colon CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Oslo University HospitalVestre Viken Hospital Trust; University Hospital of North Norway; Ostfold Hospital... and other collaboratorsRecruitingCancer MetastaticNorway
Clinical Trials on Cyclophosphamide
-
Children's Hospital Los AngelesLucile Packard Children's HospitalTerminatedMetabolic Diseases | Stem Cell Transplantation | Chronic Granulomatous Disease | Bone Marrow Transplantation | Thalassemia | Wiskott-Aldrich Syndrome | Genetic Diseases | Peripheral Blood Stem Cell Transplantation | Pediatrics | Diamond-Blackfan Anemia | Allogeneic Transplantation | Combined Immune Deficiency | X-linked Lymphoproliferative Disease
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedAnemia, AplasticUnited States
-
Columbia UniversityUnknownSevere Combined Immunodeficiency | Fanconi Anemia | Bone Marrow Failure | OsteopetrosisUnited States
-
National Cancer Institute, NaplesImmatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1CompletedHepatocellular CarcinomaBelgium, Germany, Italy, Spain, United Kingdom
-
Centre Oscar LambretCompleted
-
Mahidol UniversityTerminatedRenal Insufficiency | InfectionThailand
-
Eisai Inc.CompletedBreast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal CancerUnited States
-
Baylor Research InstituteCompletedMalignant Melanoma Stage IVUnited States
-
University of Turin, ItalyUnknown
-
Merck KGaA, Darmstadt, GermanyCompleted