Metastatic Beast CancerPhase 2NCT01963481
Exemestane and Cyclophosphamide for Metastatic Breast Cancer
A Phase 2 study testing Exemestane and Cyclophosphamide in people with Metastatic Beast Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Beast Cancer
- What is being tested?
- Exemestane and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 1 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Beast Cancer
- Being tested
- Exemestane, Cyclophosphamide
- Keywords
- hormonal therapy, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
CyclophosphamideDrug
Also called Cytoxan, CTX
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Exemestane; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Response Rate (RR) - Complete Response and Partial Response
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.
Measured: 2 years
Clinical Benefit Rate Score
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Beast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia Adams, MD, Principal investigator, NYU Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963481
- Sponsor's protocol ID
- 13-00761
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2013
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 29124456
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01963481
- Acronym / sponsor ID
- 13-00761
- Conditions
- Metastatic Beast Cancer
- Keywords
- hormonal therapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane and cyclophosphamide | Experimental | Drug: Exemestane, Drug: CyclophosphamideA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExemestaneAlso: Aromasin | Drug | Exemestane and cyclophosphamide |
| CyclophosphamideAlso: Cytoxan, CTX | Drug | Exemestane and cyclophosphamide |
Primary outcome
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.
2 secondary outcomes
Response Rate (RR) - Complete Response and Partial Response
Time frame: 2 years
Clinical Benefit Rate Score
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29124456Kwa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Adams, MD principal investigator
NYU Perlmutter Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exemestane and Cyclophosphamide in people with Metastatic Beast Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) Rate at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.