Breast Cancer Stage IPhase 2NCT06806930
Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
A Phase 2 study testing Neoadjuvant endocrine therapy in people with Breast Cancer Stage I and Breast Cancer Stage II, run by George Washington University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are: 1. How breast cancer responds to endocrine therapy given prior to surgery? 2. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- Neoadjuvant endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
- Clinical stage 1 to 3 breast cancer
- Candidate for surgical resection
- Estrogen receptor > 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
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- HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
- Ability to take oral medication
- Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
- Age ≥ 21 years
Who cannot join
- Inability to comply taking NET
- Inability to comply to study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Richard Lush, PhD, 202-994-0329, rmlush3@gwu.edu
About this study
The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:
- How breast cancer responds to endocrine therapy given prior to surgery?
- To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C
Read more
Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:
- receive endocrine therapy as part of regular care for breast cancer
- consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor
- participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed
- Being tested
- Neoadjuvant endocrine therapy
- Keywords
- breast, cancer, HER2, carcinoma
- Medical subject headings
- Breast Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant endocrine therapyDrug
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks)
Neoadjuvant endocrine therapyDrug
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET > 8weeks but <=24 weeks
Neoadjuvant endocrine therapyDrug
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Short Duration NET | Active comparator | Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks) Receives: Drug: Neoadjuvant endocrine therapy |
| Cohort B: Intermediate Duration NET | Active comparator | Patients in this cohort can be treated with NET > 8weeks but <=24 weeks Receives: Drug: Neoadjuvant endocrine therapy |
| Cohort C: Extended Duration NET | Active comparator | Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks Receives: Drug: Neoadjuvant endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to neoadjuvant endocrine therapy (NET)
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins >1mm; Failure is defined as margins ≤1mm.
Measured: From enrollment to the end of treatment at <=52 weeks
Secondary outcomes (2)
Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.
Measured: From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.
Measured: From enrollment to the end of treatment at <=52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Oct 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavani Chalasani, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806930
- Sponsor's protocol ID
- Neo-PREDICT
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
- ClinicalTrials.gov ID
- NCT06806930
- Acronym / sponsor ID
- Neo-PREDICT
- Keywords
- breast, cancer, HER2, carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Feb 2025 (actual)
- 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 trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:
- How breast cancer responds to endocrine therapy given prior to surgery?
- To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C
Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:
- receive endocrine therapy as part of regular care for breast cancer
- consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor
- participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Short Duration NET | Active comparator | Drug: Neoadjuvant endocrine therapyPatients in this cohort can be treated with NET up to 8weeks (<= 8 weeks) |
| Cohort B: Intermediate Duration NET | Active comparator | Drug: Neoadjuvant endocrine therapyPatients in this cohort can be treated with NET > 8weeks but <=24 weeks |
| Cohort C: Extended Duration NET | Active comparator | Drug: Neoadjuvant endocrine therapyPatients in this cohort can be treated with NET >24 weeks but <= 52 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
- Clinical stage 1 to 3 breast cancer
- Candidate for surgical resection
Key exclusion criteria (2 listed)
- Inability to comply taking NET
- Inability to comply to study procedures
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 |
|---|---|---|
| Neoadjuvant endocrine therapyCohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks) | Drug | Cohort A: Short Duration NET |
| Neoadjuvant endocrine therapyCohort B: Intermediate duration NET. Patients in this cohort can be treated with NET > 8weeks but <=24 weeks | Drug | Cohort B: Intermediate Duration NET |
| Neoadjuvant endocrine therapyCohort C: Extended duration NET. Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks | Drug | Cohort C: Extended Duration NET |
Primary outcome
Response to neoadjuvant endocrine therapy (NET)
Time frame: From enrollment to the end of treatment at <=52 weeks
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins >1mm; Failure is defined as margins ≤1mm.
2 secondary outcomes
Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
Time frame: From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
Time frame: From enrollment to the end of treatment at <=52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Neoadjuvant endocrine therapy in people with Breast Cancer Stage I and Breast Cancer Stage II, run by George Washington University 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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Mar 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pavani Chalasani, MD (202-741-2277, pchalasani@mfa.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to neoadjuvant endocrine therapy (NET) (time frame: From enrollment to the end of treatment at <=52 weeks). 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 3 Mar 2026.