Breast CancerPhase 2NCT00201864
Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
A Phase 2 study testing Exemestane and Fulvestrant in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exemestane and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Feb 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven breast cancer
- Metastatic or locally advanced breast cancer
- Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
- Postmenopausal status
- No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Adequate organ function
Who cannot join
- No prior Exemestane or Fulvestrant
- Uncontrolled intercurrent illness including but not limited to:
- ongoing or active infection
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
Show all 10Show fewer
- myocardial infarction within the last 3 months
- psychiatric illness/social situations that would limit compliance with study
- Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
- Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.
- Conditions
- Breast Cancer
- Being tested
- Exemestane, Fulvestrant
- Keywords
- Postmenopausal, Women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
25 mg orally per day
FulvestrantDrug
Also called Faslodex
250 mg IM starting on Day 8 and then every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| single-arm study | Experimental | Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection Receives: Drug: Exemestane; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.
TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Every 2 cycles up to 2 years
Secondary outcomes (3)
Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)
Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.
Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR
Measured: Every 2 cycles, up to 1 year
Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant
5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.
Measured: Day 7 and Day 120
Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels
Measured: Prestudy, Day 7 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2012
- Study completionFeb 2014
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Ewa Mrozek, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201864
- Sponsor's protocol ID
- OSU-0494
- Other IDs
- NCI-2011-03154
- Status last verified
- Jun 2018
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mrozek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003.
PubMed 22444722
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00201864
- Acronym / sponsor ID
- OSU-0494
- Conditions
- Breast Cancer
- Keywords
- Postmenopausal, Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study | Experimental | Drug: Exemestane, Drug: FulvestrantCombination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Proven breast cancer
- Metastatic or locally advanced breast cancer
- Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
- Postmenopausal status
- No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
Key exclusion criteria (10 listed)
- No prior Exemestane or Fulvestrant
- Uncontrolled intercurrent illness including but not limited to:
- Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
- Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
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: Aromasin25 mg orally per day | Drug | single-arm study |
| FulvestrantAlso: Faslodex250 mg IM starting on Day 8 and then every 28 days. | Drug | single-arm study |
Primary outcome
Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.
Time frame: Every 2 cycles up to 2 years
TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
3 secondary outcomes
Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)
Time frame: Every 2 cycles, up to 1 year
Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant
Time frame: Day 7 and Day 120
Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels
Time frame: Prestudy, Day 7 and Day 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22444722Mrozek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003.
- JameslineLink provided by the sponsor.
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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.
Ewa Mrozek, MD principal investigator
Ohio State University
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 Fulvestrant in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center 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 7 inclusion and 10 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 26 Jul 2018. 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 15 Aug 2016). 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?
Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. (time frame: Every 2 cycles up to 2 years). 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 NCT00201864, 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 26 Jul 2018.