Breast CancerNCT02095184
GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients
A study testing Anastrozole and Letrozole in people with Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. 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?
- Anastrozole and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2015to 2 Aug 2024
- Phase
- Interventional
- 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
- Female greater than or equal to 18 years.
- Postmenopausal status, defined by no menstrual cycle for 12 months or surgical removal of ovaries.
- Histologically confirmed adenocarcinoma of the breast.
- Evidence of hormone sensitive, ER rich primary tumor defined by an Allred score of ≥6.
- Human estrogen receptor -2 (HER2) negative in the primary tumor tissue as defined by:
- Grade 0 or 1+ staining intensity (on a scale of 0 to 3) by means of IHC analysis OR
Show all 17Show fewer
- Grade 2+ staining intensity by means of immuno-histochemical (IHC) analysis with gene amplification on fluorescence in situ hybridization (FISH) < 2.0 OR
- Gene amplification on fluorescence in situ hybridization (FISH) < 2.0.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Unresected operable breast cancer stage I-III with primary tumor ≥ 2.0 cm.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy.
- Patients must have an adequate tumor tissue sample prior to enrollment available for correlative studies as defined below: Core needle biopsy or incisional biopsy samples that can provide ≥ 5 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient.
- Patients must have adequate organ function as defined below:
- Total bilirubin within normal institutional limits
- aspartate aminotransferase (AST)(SGOT)/alanine aminotransferase (ALT)(SGPT) < 2.5 x institutional upper limit of normal
- Creatinine clearance ≥ 10 mL/min/1.73 m2
Who cannot join
- Previous or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin.
- Patients may not be receiving any other investigational agent.
- History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to anastrozole or letrozole.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
About this study
Official title: GCC 1366: A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors to Evaluate Anti-Proliferative Response in Obese and Overweight Patients
More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. The female hormone estrogen is an important hormone for the growth of breast cancer cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food and Drug Administration (FDA). They have been used since 2005 to treat women with early stage breast cancer.
When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients. In over 50% of patients, anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy.
Read more
One of the things may influence the level of hormone is body weight. It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer. This is likely due to an increase in aromatase activity in the fatty tissue. However, at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight. Currently, we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat.
The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat.
Read the detailed description
GCC 1366 is a prospective randomized window trial to evaluate the anti-proliferative response in obese and overweight breast cancer patients treated with neoadjuvant non-steroidal aromatase inhibitors. Post-menopausal women over the age of 18 years with estrogen receptor positive Her 2 neu negative stage II-III breast cancer are eligible. Participants will be randomized according to BMI to neoadjuvant treatment with Arimidex or Letrozole.
A total of 90 patients will be enrolled with 15 patients in each cohort below.
- Cohort 1: Patients with BMI < 25.0 kg/m2 treating with anastrozole
- Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with anastrozole
- Cohort 3: Patients with BMI ≥ 30 kg/m2 treating with anastrozole
- Cohort 4: Patients with BMI < 25.0 kg/m2 treating with letrozole
- Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
- Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Based on the patients' calculated BMI, patients in each BMI category (normal, overweight, and obese) will be enrolled in the different cohorts as described above. The first 15 patients in each BMI category will be treated with anastrozole. After completion of enrollment in cohorts 1, 2, and 3, subsequent patients will be treated with letrozole in cohorts 4, 5, and 6.
Anastrozole 1 mg or Letrozole 2.5 mg oral daily will be administered and continued for a minimum of 14 days and a maximum of 28 days (2-4 weeks). Surgery will be performed between weeks 2-3 of treatment unless there are compelling medical or personal reasons that prevent a patient from having surgery during this time. In those cases, patients may continue anastrozole or letrozole up to 4 weeks before surgery. Surgery should be performed within 36 hours of the last dose of anastrozole or letrozole.
Tumor tissue that is obtained for diagnosis or to assess response to initial AI therapy will be utilized for correlative studies. A patient may be continued on anastrozole or letrozole beyond 4 weeks (up to 18 weeks) if in the opinion of the treating physician, the patient will benefit from extended endocrine therapy. In this context, patients will have a core needle biopsy performed at 2-4 weeks after treatment to assess Ki67 response to AI therapy. Patients with an appropriate response to treatment as determined by a decrease in Ki67 levels (≤10%) will be continued on AI treatment. Patients without an appropriate decrease in Ki67 levels will be recommended to have immediate surgery or a switch to neoadjuvant chemotherapy if desired by the patient and treating physician.
Patients on extended AI neoadjuvant treatment having core biopsy at 2-4 weeks for Ki67 determination for clinical decision making will be approached and consented for additional research tissues to be taken at the same time as the biopsy for Ki67 determination. Blood samples will be collected prior to starting treatment and within 3 days or on the day of surgery. Additional blood samples will be obtained as clinically necessary.
Clinical assessment will be performed prior to enrollment and within 3 days or on the day of surgery. For patients who continue neoadjuvant endocrine therapy past 4 weeks, clinical assessment will be performed at the time of clinical biopsy and every 4-6 weeks thereafter. For clinical evidence of progression, patients will be offered immediate surgery or switch to neoadjuvant chemotherapy at the discretion of the treating physician.
Radiological assessment including mammogram, ultrasound, and breast MRI will be performed as per standard of care.
Patients will be followed for 30 days on study after the last dose of anastrozole or letrozole prior to surgery. For patients who receive extended neoadjuvant therapy with anastrozole or letrozole and for patients who receive other primary treatment after anastrozole or letrozole administration prior to surgery, patients will be followed for 30 days on study after the last dose of anastrozole or letrozole. Patients continuing to experience adverse events attributable to anastrozole or letrozole will be followed as needed until resolution or stabilization of the adverse events. Patients who are either found to be ineligible or refuse to start treatment after consenting will not be followed and will be replaced. Their information will not be collected. After 30 days after the last dose of anastrozole or letrozole, if there are no continuing adverse events attributable to treatment, patients will be off study.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Letrozole
- Keywords
- Breast Cancer, Postmenopausal, Hormone-Receptor Positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
1 mg daily
LetrozoleDrug
Also called Femara
2.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Normal Weight Anastrozole | Active comparator | Cohort 1: Patients with BMI < 25.0 kg/m2 treated with anastrozole Receives: Drug: Anastrozole |
| Cohort 2: Overweight Anastrozole | Active comparator | Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole Receives: Drug: Anastrozole |
| Cohort 3: Obese | Active comparator | Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole Receives: Drug: Anastrozole |
| Cohort 4: Normal Weight Letrozole | Active comparator | Cohort 4: Patients with BMI < 25.0 kg/m2 treating with letrozole Receives: Drug: Letrozole |
| Cohort 5: Overweight Letrozole | Active comparator | Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole Receives: Drug: Letrozole |
| Cohort 6: Obese Letrozole | Active comparator | Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Proliferative Index (Ki67) After Treatment With the Standard Dose Anastrozole or Letrozole in Normal, Obese, and Overweight Patients
Core biopsy
Measured: 2-4 weeks Post-treatment
Secondary outcomes (9)
To Evaluate Differences in Baseline GP88 Level
GP88-6ml Blood Serum Sample
Measured: B,0-Prior to starting anastrozole or letrozole
To Evaluate Differences in Baseline GP88 Level
GP88-6ml Blood Serum Sample
Measured: B,1-On the day of surgery or within 3 days of surgery
To Evaluate Differences in Baseline GP88 Level
GP88-6ml Blood Serum Sample
Measured: B,2-obtained 2-4 weeks after initiation of AI therapy( for persons rec. extended neoadjuvant tx)
To Assess Estradiol Levels at Baseline and After Treatment (in Primary ER Positive Breast Tumors)
10ml Blood Serum Sample
Measured: Baseline
To Assess Estradiol Levels at Baseline and After Treatment (in Primary ER Positive Breast Tumors)
10ml Blood Serum Sample
Measured: 2-4 weeks Post treatment
To Evaluate the Association of AI-induced Ki67 Response
(IHC)--Immunohistochemistry
Measured: Baseline
To Evaluate the Association of AI-induced Ki67 Response
(IHC)--Immunohistochemistry
Measured: 2-4 weeks Post-Treatment
To Evaluate Differences in Oncotype Dx
Tumor Tissue Assay
Measured: Baseline(T0)
To Evaluate Differences in Oncotype Dx
Tumor Tissue Assay
Measured: 2-4 Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study start25 May 2015
- Primary completion24 Jul 2024
- Study completion2 Aug 2024
Why it stopped: This study was terminated due to slow accrual, and this due to the changing practice patterns, and difficulties with insurance coverage for some of the study related tests, such as OncotypeDx.
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily C Bellavance, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095184
- Sponsor's protocol ID
- HP-00060250
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2014
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCC 1366: A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors to Evaluate Anti-Proliferative Response in Obese and Overweight Patients
- ClinicalTrials.gov ID
- NCT02095184
- Acronym / sponsor ID
- HP-00060250
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Postmenopausal, Hormone-Receptor Positive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to slow accrual, and this due to the changing practice patterns, and difficulties with insurance coverage for some of the study related tests, such as OncotypeDx.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 25 May 2015 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. The female hormone estrogen is an important hormone for the growth of breast cancer cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food and Drug Administration (FDA). They have been used since 2005 to treat women with early stage breast cancer.
When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients. In over 50% of patients, anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy.
One of the things may influence the level of hormone is body weight. It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer. This is likely due to an increase in aromatase activity in the fatty tissue. However, at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight. Currently, we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat.
The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat.
Detailed description
GCC 1366 is a prospective randomized window trial to evaluate the anti-proliferative response in obese and overweight breast cancer patients treated with neoadjuvant non-steroidal aromatase inhibitors. Post-menopausal women over the age of 18 years with estrogen receptor positive Her 2 neu negative stage II-III breast cancer are eligible. Participants will be randomized according to BMI to neoadjuvant treatment with Arimidex or Letrozole.
A total of 90 patients will be enrolled with 15 patients in each cohort below.
- Cohort 1: Patients with BMI < 25.0 kg/m2 treating with anastrozole
- Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with anastrozole
- Cohort 3: Patients with BMI ≥ 30 kg/m2 treating with anastrozole
- Cohort 4: Patients with BMI < 25.0 kg/m2 treating with letrozole
- Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
- Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole
Based on the patients' calculated BMI, patients in each BMI category (normal, overweight, and obese) will be enrolled in the different cohorts as described above. The first 15 patients in each BMI category will be treated with anastrozole. After completion of enrollment in cohorts 1, 2, and 3, subsequent patients will be treated with letrozole in cohorts 4, 5, and 6.
Anastrozole 1 mg or Letrozole 2.5 mg oral daily will be administered and continued for a minimum of 14 days and a maximum of 28 days (2-4 weeks). Surgery will be performed between weeks 2-3 of treatment unless there are compelling medical or personal reasons that prevent a patient from having surgery during this time. In those cases, patients may continue anastrozole or letrozole up to 4 weeks before surgery. Surgery should be performed within 36 hours of the last dose of anastrozole or letrozole.
Tumor tissue that is obtained for diagnosis or to assess response to initial AI therapy will be utilized for correlative studies. A patient may be continued on anastrozole or letrozole beyond 4 weeks (up to 18 weeks) if in the opinion of the treating physician, the patient will benefit from extended endocrine therapy. In this context, patients will have a core needle biopsy performed at 2-4 weeks after treatment to assess Ki67 response to AI therapy. Patients with an appropriate response to treatment as determined by a decrease in Ki67 levels (≤10%) will be continued on AI treatment. Patients without an appropriate decrease in Ki67 levels will be recommended to have immediate surgery or a switch to neoadjuvant chemotherapy if desired by the patient and treating physician.
Patients on extended AI neoadjuvant treatment having core biopsy at 2-4 weeks for Ki67 determination for clinical decision making will be approached and consented for additional research tissues to be taken at the same time as the biopsy for Ki67 determination. Blood samples will be collected prior to starting treatment and within 3 days or on the day of surgery. Additional blood samples will be obtained as clinically necessary.
Clinical assessment will be performed prior to enrollment and within 3 days or on the day of surgery. For patients who continue neoadjuvant endocrine therapy past 4 weeks, clinical assessment will be performed at the time of clinical biopsy and every 4-6 weeks thereafter. For clinical evidence of progression, patients will be offered immediate surgery or switch to neoadjuvant chemotherapy at the discretion of the treating physician.
Radiological assessment including mammogram, ultrasound, and breast MRI will be performed as per standard of care.
Patients will be followed for 30 days on study after the last dose of anastrozole or letrozole prior to surgery. For patients who receive extended neoadjuvant therapy with anastrozole or letrozole and for patients who receive other primary treatment after anastrozole or letrozole administration prior to surgery, patients will be followed for 30 days on study after the last dose of anastrozole or letrozole. Patients continuing to experience adverse events attributable to anastrozole or letrozole will be followed as needed until resolution or stabilization of the adverse events. Patients who are either found to be ineligible or refuse to start treatment after consenting will not be followed and will be replaced. Their information will not be collected. After 30 days after the last dose of anastrozole or letrozole, if there are no continuing adverse events attributable to treatment, patients will be off study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Normal Weight Anastrozole | Active comparator | Drug: AnastrozoleCohort 1: Patients with BMI < 25.0 kg/m2 treated with anastrozole |
| Cohort 2: Overweight Anastrozole | Active comparator | Drug: AnastrozoleCohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole |
| Cohort 3: Obese | Active comparator | Drug: AnastrozoleCohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole |
| Cohort 4: Normal Weight Letrozole | Active comparator | Drug: LetrozoleCohort 4: Patients with BMI < 25.0 kg/m2 treating with letrozole |
| Cohort 5: Overweight Letrozole | Active comparator | Drug: LetrozoleCohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole |
| Cohort 6: Obese Letrozole | Active comparator | Drug: LetrozoleCohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female greater than or equal to 18 years.
- Postmenopausal status, defined by no menstrual cycle for 12 months or surgical removal of ovaries.
- Histologically confirmed adenocarcinoma of the breast.
- Evidence of hormone sensitive, ER rich primary tumor defined by an Allred score of ≥6.
- Human estrogen receptor -2 (HER2) negative in the primary tumor tissue as defined by:
Key exclusion criteria (3 listed)
- Previous or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin.
- Patients may not be receiving any other investigational agent.
- History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to anastrozole or letrozole.
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 |
|---|---|---|
| AnastrozoleAlso: Arimidex1 mg daily | Drug | Cohort 1: Normal Weight Anastrozole, Cohort 2: Overweight Anastrozole, Cohort 3: Obese |
| LetrozoleAlso: Femara2.5 mg daily | Drug | Cohort 4: Normal Weight Letrozole, Cohort 5: Overweight Letrozole, Cohort 6: Obese Letrozole |
Primary outcome
Percent Change in Proliferative Index (Ki67) After Treatment With the Standard Dose Anastrozole or Letrozole in Normal, Obese, and Overweight Patients
Time frame: 2-4 weeks Post-treatment
Core biopsy
9 secondary outcomes
To Evaluate Differences in Baseline GP88 Level
Time frame: B,0-Prior to starting anastrozole or letrozole
To Evaluate Differences in Baseline GP88 Level
Time frame: B,1-On the day of surgery or within 3 days of surgery
To Evaluate Differences in Baseline GP88 Level
Time frame: B,2-obtained 2-4 weeks after initiation of AI therapy( for persons rec. extended neoadjuvant tx)
To Assess Estradiol Levels at Baseline and After Treatment (in Primary ER Positive Breast Tumors)
Time frame: Baseline
To Assess Estradiol Levels at Baseline and After Treatment (in Primary ER Positive Breast Tumors)
Time frame: 2-4 weeks Post treatment
To Evaluate the Association of AI-induced Ki67 Response
Time frame: Baseline
To Evaluate the Association of AI-induced Ki67 Response
Time frame: 2-4 weeks Post-Treatment
To Evaluate Differences in Oncotype Dx
Time frame: Baseline(T0)
To Evaluate Differences in Oncotype Dx
Time frame: 2-4 Post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emily C Bellavance, M.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anastrozole and Letrozole in people with Breast Cancer, run by University of Maryland, Baltimore 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 17 inclusion and 3 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 15 Apr 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). 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?
Percent Change in Proliferative Index (Ki67) After Treatment With the Standard Dose Anastrozole or Letrozole in Normal, Obese, and Overweight Patients (time frame: 2-4 weeks Post-treatment). 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 15 Apr 2026.