A Phase 1/2 interventional study of Exemestane and Sutent in Metastatic Breast Cancer, sponsored by Baylor Breast Care Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Baylor Breast Care Center · Phase 1/2, Interventional, and Treatment
Among 29 studies testing sunitinib in Breast Neoplasms — 1 open to participants now, 2 under way, none of them phase 3. Sunitinib · Breast Neoplasms.
Among the 29 studies testing sunitinib in Breast Neoplasms, this one is the 27th largest by enrollment, is the only one that started in 2010, is one of 5 in phase 1/2, and was the 23rd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →1 of the 29 studies testing sunitinib in Breast Neoplasms is open now, in 1 country. Each count lists the studies.
Sunitinib: first FDA approval 2006 (SUTENT), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →29 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2010.
Median enrollment 60 across the 29 interventional studies. Of the 25 that completed or were terminated, 18 (72%) have results posted.
15 of 29 have an industry lead sponsor. The 10 most frequent:
Baylor Breast Care Center is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
16 studies in Breast Neoplasms by Baylor Breast Care Center: 1 open now, 3 under way, none of them phase 3. Of 12 finished, 6 (50%) have results posted.
Among the 16 studies in Breast Neoplasms by Baylor Breast Care Center, this one is the 14th largest by enrollment, is the only one that started in 2010, is the only one in phase 1/2, and was the 12th registered.
Baylor Breast Care Center’s Breast Neoplasms studies by the year they started, since 1999.
None of the studies under way reaches primary completion within a year.
Among the 29 studies testing sunitinib in Breast Neoplasms, from their registry updates:
Among Baylor Breast Care Center’s 16 in Breast Neoplasms:
Nothing recorded among them since 2026-09-25.
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.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Exemestane · Drug: Sutent
Exemestane 25 mg by mouth every day.
Also known as: Aromasin
Sunitinib 37.5 mg by mouth every day.
Also known as: (Sunitinib)
Time to Disease Progression in Weeks
Time from the first day of treatment to date of 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
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
| Milestone | Exemestane Plus Sutent |
|---|---|
| Started | 4 |
| Completed | 2 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
Time from the first day of treatment to date of progression in weeks
| week | Exemestane Plus Sunitinib |
|---|---|
| Time to Disease Progression in Weeks | 11.1 (10.9 to 11.3) |
| paticipants | Exemestane Plus Sunitinib |
|---|---|
| Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival | NA |
| Participants | Exemestane Plus Sunitinib |
|---|---|
| Determine the Safety and Tolerability | NA |
| cell | Exemestane Plus Sunitinib |
|---|---|
| Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells | NA (NA to NA) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exemestane Plus Sutent | — | 1/4 (25%) | 4/4 (100%) |
| Event | Exemestane Plus Sutent |
|---|---|
| HypertriglyceridaemiaMetabolism and nutrition disorders | 1/4 |
| Event | Exemestane Plus Sutent |
|---|---|
| leukopeniaBlood and lymphatic system disorders | 4/4 |
| HypertensionCardiac disorders | 3/4 |
| Dermatology/SkinSkin and subcutaneous tissue disorders | 2/4 |
| Mucositis/stomatitisGastrointestinal disorders | 2/4 |
| plateletsBlood and lymphatic system disorders | 2/4 |
| Rash: acne/acneiformSkin and subcutaneous tissue disorders | 2/4 |
| Thyroid function, lowEndocrine disorders | 2/4 |
| AST, SGOT(serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders | 1/4 |
| Alkaline phosphataseMetabolism and nutrition disorders | 1/4 |
| DizzinessNervous system disorders | 1/4 |
| Age, Categorical(Participants) | Exemestane Plus Sutent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Exemestane Plus Sutent |
|---|---|
| Female | 4 |
| Male | 0 |
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sunitinib
Baylor Breast Care Center