Metastatic Breast CancerPhase 1/2EXTENTNCT00905021
Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer
A Phase 1/2 study testing Exemestane and Sutent in people with Metastatic Breast Cancer, run by Baylor Breast Care Center at 1 site in United States.
Trial summary
The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Exemestane and Sutent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2012
- Phase
- Phase 1/2
- 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
- Must have metastatic breast cancer or locally advanced not amenable to curative therapy.
- Measurable or evaluable disease are eligible.
- Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive.
- Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy.
- Postmenopausal
- No more than 3 lines of chemotherapy
Show all 15Show fewer
- No more than 3 lines of hormonal therapy
- Bisphosphonates may be given according to their product license
- Left ventricular ejection fraction within institutional normal limits
- Liver function and kidney function tests within the upper limit of normal. In patients with liver metastasis, liver function tests should be < 5 times the upper limit of normal.
- Adequate blood counts
- Normal thyroid function tests.
- Patients with Central Nervous System (CNS) metastatic disease are allowed if the disease is stable for more than 3 months by CT or MRI.
- Adequate general health (Eastern Cooperative Oncology Group (ECOG) performance status 0-2).
- Able to give informed consent and follow the procedures of the study.
Who cannot join
- Patients previously treated with exemestane in any setting.
- Patients previously treated with sunitinib.
- Patients with cardiac dysfunction or active cardiac disease
- Patients with uncontrolled CNS metastasis.
- Poorly controlled hypertension
- Blood counts or liver and kidney tests that fall outside the ranges outlined in inclusion criteria 9-10 above.
Show all 15Show fewer
- ECOG performance status 3 or 4.
- History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- History of a cerebrovascular accident, non-catheter related deep vein thrombosis, or pulmonary embolism in the last 5 years.
- Major surgical procedure or significant traumatic injury within 28 days prior to study entry.
- Premenopausal status.
- History of receiving any investigational treatment within 28 days of study medication initiation.
- Current known infection.
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- Medical or psychiatric condition that in the opinion of the principal investigator impair their ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine, Lester and Sue Smith Breast Center
Houston, Texas, 77030
About this study
Official title: EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer
The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. The investigators want to see if there are any changes that could show us if your cancer is responding to the study treatments.
Read the detailed description
The study design is a phase II design. Eligible patients will undergo staging work up and start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations will be performed every 4 weeks and staging work up will be repeated every 12 weeks.
The primary objective of the study is to assess progression free survival (PFS) of treatment with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive (ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer subjects who have progressed on prior hormonal treatment.
In addition we want to:
- Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS).
- Determine the safety and tolerability of the combination regimen.
- Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and circulating endothelial cells (CECs), and explore associations with treatment response and resistance.
- Blood samples will be drawn for enumeration and profiling of circulating tumor cells and circulating endothelial cells at study entry (prior to starting study medications), four weeks after starting study medications, twelve weeks after starting study medications and at disease progression. These samples will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
- If the patient participating on the study has an easily accessible breast mass or metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core needle or punch biopsy will be obtained at study entry (prior to starting study medications), four weeks after starting study medications, and at disease progression. These biopsies will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Exemestane, Sutent
- Keywords
- Breast Cancer, Metastatic, Hormone Receptor Positive
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
Exemestane 25 mg by mouth every day.
SutentDrug
Also called (Sunitinib)
Sunitinib 37.5 mg by mouth every day.
| Study group | Role | What they receive |
|---|---|---|
| Exemestane plus Sutent | Experimental | All patients enrolled on the study will receive treatment as follows:
1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day. Receives: Drug: Exemestane; Drug: Sutent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression in Weeks
Time from the first day of treatment to date of progression in weeks
Measured: Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance
Secondary outcomes (3)
Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival
Measured: 5 years
Determine the Safety and Tolerability
Measured: 5 years
Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionFeb 2012
Why it stopped: Sponsor withdrew support
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.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Breast Care Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Mothaffar Rimawi, Baylor Breast Care Center
- Investigators
- Mothaffar Rimiawi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905021
- Sponsor's protocol ID
- H 24786 / EXTENT
- Acronym
- EXTENT
- Status last verified
- Jul 2020
- First submitted
- 18 May 2009
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXTENT: Exemestane (AROMASIN®) in Combination With Sunitinib (SUTENT®) in Hormone Receptor Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00905021
- Acronym / sponsor ID
- EXTENT / H 24786 / EXTENT
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, Metastatic, Hormone Receptor Positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew support
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baylor Breast Care CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. The investigators want to see if there are any changes that could show us if your cancer is responding to the study treatments.
Detailed description
The study design is a phase II design. Eligible patients will undergo staging work up and start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations will be performed every 4 weeks and staging work up will be repeated every 12 weeks.
The primary objective of the study is to assess progression free survival (PFS) of treatment with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive (ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer subjects who have progressed on prior hormonal treatment.
In addition we want to:
- Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS).
- Determine the safety and tolerability of the combination regimen.
- Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and circulating endothelial cells (CECs), and explore associations with treatment response and resistance.
- Blood samples will be drawn for enumeration and profiling of circulating tumor cells and circulating endothelial cells at study entry (prior to starting study medications), four weeks after starting study medications, twelve weeks after starting study medications and at disease progression. These samples will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
- If the patient participating on the study has an easily accessible breast mass or metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core needle or punch biopsy will be obtained at study entry (prior to starting study medications), four weeks after starting study medications, and at disease progression. These biopsies will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane plus Sutent | Experimental | Drug: Exemestane, Drug: SutentAll patients enrolled on the study will receive treatment as follows: 1. Exemestane 25 mg by mouth every day. 2. Sunitinib 37.5 mg by mouth every day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must have metastatic breast cancer or locally advanced not amenable to curative therapy.
- Measurable or evaluable disease are eligible.
- Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive.
- Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy.
- Postmenopausal
Key exclusion criteria (15 listed)
- Patients previously treated with exemestane in any setting.
- Patients previously treated with sunitinib.
- Patients with cardiac dysfunction or active cardiac disease
- Patients with uncontrolled CNS metastasis.
- Poorly controlled hypertension
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: AromasinExemestane 25 mg by mouth every day. | Drug | Exemestane plus Sutent |
| SutentAlso: (Sunitinib)Sunitinib 37.5 mg by mouth every day. | Drug | Exemestane plus Sutent |
Primary outcome
Time to Disease Progression in Weeks
Time frame: Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance
Time from the first day of treatment to date of progression in weeks
3 secondary outcomes
Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival
Time frame: 5 years
Determine the Safety and Tolerability
Time frame: 5 years
Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Mothaffar Rimiawi, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exemestane and Sutent in people with Metastatic Breast Cancer, run by Baylor Breast Care 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 15 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 28 May 2012). 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 Disease Progression in Weeks (time frame: Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.