Breast CancerPhase 1NCT00933309
The Impact of Obesity and Obesity Treatments on Breast Cancer
A Phase 1 study testing Exemestane and Avandamet in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body. 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 Avandamet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Overweight or obese postmenopausal women with a history of biopsy-proven estrogen receptor positive and/or progesterone receptor positive breast cancer and clinical evidence of metastatic disease. Overweight and obesity are defined by the WHO as a BMI of 25 - 29.9 and >/= 30 kg/m^2 respectively. Postmenopausal status is defined by one of the following: a) no spontaneous menses for over 1 year, in women >55 years; Continued in inclusion criterion # 2.
- Continuation from inclusion #1: b) no spontaneous menses within the past 1 year in women </= 55 years with postmenopausal gonadotrophin levels (LH and FSH levels > 40 IU/L) or postmenopausal estradiol levels (<10 pg/mL); or c) bilateral oophorectomy.
- Prior endocrine therapy, biologic therapy and chemotherapy are allowed, either in the adjuvant setting or for metastatic breast cancer.
- Prior exemestane, metformin, or rosiglitazone is allowed if taken longer than 7 days prior to enrollment.
- Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
- Performance status </= 2 ECOG.
- Absolute neutrophil count (ANC) >/= 1000/µl, platelets >/= 75,000/µl, hemoglobin >/= 8.5 gm/dL; serum creatinine < 1.4 mg/dL; bilirubin < 1.8 mg/dL; ALT or AST </= 2.5 x ULN if no demonstrable liver metastases or </= 5 x ULN in presence of liver metastases; alkaline phosphatase < 3 x upper limit of normal; calcium </= 11.0 mg/dL.
- Patients must be competent to give informed consent and to state that they understand the investigational nature of the proposed treatment.
Who cannot join
- Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, e.g., whole pelvis or half spine).
- Uncontrolled diabetes mellitus (hemoglobin A1C > 9 or random plasma glucose > 400 mg/dL).
- History of acromegaly, Cushing's syndrome, Cushing's disease, Addison's disease (treated or untreated).
- Patients with unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
- Concurrently receiving and are unwilling to discontinue hormonal (estrogen with or without progesterone) replacement therapy.
- Other investigational drugs within the past 3 weeks or concurrently.
Show all 13Show fewer
- Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Laboratory results sustained at: International normalized ratio (INR) > 1.6; ALT or AST > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in presence of liver metastasis; No more than 3 retests within screening period
- Patients with known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients who received chemotherapy within 3 weeks (6 weeks for nitrosourea or mitomycin-C). Acute toxicities from prior therapy must have resolved to Grade </= 1 with the exception of fatigue, alopecia, or anemia.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol e.g., severe renal or hepatic impairment or currently unstable or uncompensated respiratory or cardiac conditions.
- History of hypersensitivity to active or inactive excipients of the study medications - exemestane or metformin.
- Untreated or clinically unstable central nervous system involvement. A patient with adequately treated brain metastases would be eligible one month after completion of surgery and/or radiation therapy if she is clinically stable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.
Read the detailed description
The Study Drugs:
Exemestane decreases the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die.
Avandamet contains two drugs commonly used to control blood sugar levels in patients with diabetes (metformin and rosiglitazone).
If you are found to be eligible to take part in this study, the dose of Avandamet you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of Avandamet. Each new group will receive a higher dose of Avandamet than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of Avandamet is found.
All participants will receive the same dose level of exemestane.
Study Drug Administration:
The study drug(s) will be given in 28-day "cycles."
You will take an exemestane tablet by mouth every day. You will also take tablets of Avandamet by mouth 1 or 2 times a day depending on the dose level to which you are assigned. You should take Avandamet at meals.
Study Visits:
On Day 1 of Cycles 2, 3, and 4, and then every 3 months after that, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your weight and vital signs.
- You will be asked about any side effects you may be having.
- You will be asked about any drugs you may have taken or may be taking.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests. This blood draw can be done up to 3 days before each cycle.
- Blood (about 1 teaspoons) will be drawn for blood sugar tests. If you have a history of diabetes, you will need to fast for 8 hours before these blood sugar tests.
Every 3 months, you will have scans to check the status of the disease. The scan performed will depend on where the disease is located in the body.
Every 3 months, you will also have an echocardiogram (ECHO) or a multi-gated acquisition (MUGA) scan to test your heart function.
Additional Blood Draws:
Blood (about 1 teaspoon each time) will also be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug(s) in the body at different time points. Blood will be drawn for PK testing before you take the study drug(s) and 1, 3, 6, 12, and 23 hours after you take the study drug(s) on Days 1, 8, and 15 of Cycle 1.
Length of Study:
You may take the study drug(s) for as long as the disease is stable and/or responding. You may be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Exemestane and Avandamet are FDA approved and commercially available. Exemestane is approved for the treatment of metastatic breast cancer. Avandamet is approved for the treatment of diabetes. The use of this drug combination is investigational.
Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Exemestane, Avandamet
- Keywords
- Breast, Obese, Obesity Treatment, Exemestane, Aromasin, Metformin and Rosiglitazone, Avandamet, Postmenopausal, Hormone-sensitive, Hormone-receptive-positive breast cancer
- Medical subject headings
- Breast Neoplasms, Obesity
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 tablets orally once a day
AvandametDrug
Also called Metformin plus rosiglitazone, Rosiglitazone and Metformin
Beginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Exemestane alone Receives: Drug: Exemestane |
| Group 2 | Experimental | Exemestane plus Avandamet Receives: Drug: Exemestane; Drug: Avandamet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: Day 1 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Francisco J. Esteva, MD, PhD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933309
- Sponsor's protocol ID
- 2008-0284
- Status last verified
- Aug 2012
- First submitted
- 3 Jul 2009
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00933309
- Acronym / sponsor ID
- 2008-0284
- Conditions
- Breast Cancer
- Keywords
- Breast, Obese, Obesity Treatment, Exemestane, Aromasin, Metformin and Rosiglitazone, Avandamet, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.
Detailed description
The Study Drugs:
Exemestane decreases the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die.
Avandamet contains two drugs commonly used to control blood sugar levels in patients with diabetes (metformin and rosiglitazone).
If you are found to be eligible to take part in this study, the dose of Avandamet you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of Avandamet. Each new group will receive a higher dose of Avandamet than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of Avandamet is found.
All participants will receive the same dose level of exemestane.
Study Drug Administration:
The study drug(s) will be given in 28-day "cycles."
You will take an exemestane tablet by mouth every day. You will also take tablets of Avandamet by mouth 1 or 2 times a day depending on the dose level to which you are assigned. You should take Avandamet at meals.
Study Visits:
On Day 1 of Cycles 2, 3, and 4, and then every 3 months after that, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your weight and vital signs.
- You will be asked about any side effects you may be having.
- You will be asked about any drugs you may have taken or may be taking.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests. This blood draw can be done up to 3 days before each cycle.
- Blood (about 1 teaspoons) will be drawn for blood sugar tests. If you have a history of diabetes, you will need to fast for 8 hours before these blood sugar tests.
Every 3 months, you will have scans to check the status of the disease. The scan performed will depend on where the disease is located in the body.
Every 3 months, you will also have an echocardiogram (ECHO) or a multi-gated acquisition (MUGA) scan to test your heart function.
Additional Blood Draws:
Blood (about 1 teaspoon each time) will also be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug(s) in the body at different time points. Blood will be drawn for PK testing before you take the study drug(s) and 1, 3, 6, 12, and 23 hours after you take the study drug(s) on Days 1, 8, and 15 of Cycle 1.
Length of Study:
You may take the study drug(s) for as long as the disease is stable and/or responding. You may be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Exemestane and Avandamet are FDA approved and commercially available. Exemestane is approved for the treatment of metastatic breast cancer. Avandamet is approved for the treatment of diabetes. The use of this drug combination is investigational.
Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ExemestaneExemestane alone |
| Group 2 | Experimental | Drug: Exemestane, Drug: AvandametExemestane plus Avandamet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Overweight or obese postmenopausal women with a history of biopsy-proven estrogen receptor positive and/or progesterone receptor positive breast cancer and clinical evidence of metastatic disease. Overweight and obesity are defined by the WHO as a BMI of 25 - 29.9 and >/= 30 kg/m^2 respectively. Postmenopausal status is defined by one of the following: a) no spontaneous menses for over 1 year, in women >55 years; Continued in inclusion criterion # 2.
- Continuation from inclusion #1: b) no spontaneous menses within the past 1 year in women </= 55 years with postmenopausal gonadotrophin levels (LH and FSH levels > 40 IU/L) or postmenopausal estradiol levels (<10 pg/mL); or c) bilateral oophorectomy.
- Prior endocrine therapy, biologic therapy and chemotherapy are allowed, either in the adjuvant setting or for metastatic breast cancer.
- Prior exemestane, metformin, or rosiglitazone is allowed if taken longer than 7 days prior to enrollment.
- Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
Key exclusion criteria (13 listed)
- Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, e.g., whole pelvis or half spine).
- Uncontrolled diabetes mellitus (hemoglobin A1C > 9 or random plasma glucose > 400 mg/dL).
- History of acromegaly, Cushing's syndrome, Cushing's disease, Addison's disease (treated or untreated).
- Patients with unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
- Concurrently receiving and are unwilling to discontinue hormonal (estrogen with or without progesterone) replacement therapy.
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®25 mg tablets orally once a day | Drug | Group 1, Group 2 |
| AvandametAlso: Metformin plus rosiglitazone, Rosiglitazone and MetforminBeginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day | Drug | Group 2 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Day 1 of each cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Francisco J. Esteva, MD, PhD study chair
UT MD Anderson 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 1 study testing Exemestane and Avandamet in people with Breast Cancer, run by M.D. Anderson 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 8 inclusion and 13 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 19 Feb 2016. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicity (DLT) (time frame: Day 1 of each cycle). 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 19 Feb 2016.