Breast CancerPhase 2NCT05150652
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
A Phase 2 study testing Anastrozole 1mg, Letrozole 2.5mg and Exemestane 25 mg in people with Breast Cancer and HER2-negative Breast Cancer, run by Irada Ibrahim-zada at 1 site in United States.
Trial summary
The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer, Node-negative Breast Cancer
- What is being tested?
- Anastrozole 1mg, Letrozole 2.5mg and Exemestane 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 10 Jun 2026
- Phase
- Phase 2
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed invasive breast cancer, clinically stage I-II.
- Clinically lymph node negative
- Eligible for anti-endocrine treatment (per medical oncologist)
- Postmenopausal women
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Progesterone receptor negativity
- High grade tumor
- Synchronous non-breast malignancy
- Receiving any other investigational agents that could impact the efficacy of this trial regimen
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
- Uncontrolled intercurrent illness
- Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.
- Being tested
- Anastrozole 1mg, Letrozole 2.5mg, Exemestane 25 mg, Tamoxifen
- Keywords
- Neoadjuvant endocrine therapy, Early stage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastrozole 1mgDrug
Also called Arimidex
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
Letrozole 2.5mgDrug
Also called Femara
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
Exemestane 25 mgDrug
Also called Aromasin
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
TamoxifenDrug
Also called Soltamox
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Endocrine Therapy | Experimental | Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen. Receives: Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Exemestane 25 mg; Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in margin status
Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.
Measured: Baseline, 6-months after neoadjuvant treatment and surgery
Secondary outcomes (3)
Residual cancer burden
The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Measured: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Pattern of response
Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)
Measured: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Change in satisfaction with cosmetic outcome
The Breast-Q© is a patient reported outcome measure for breast surgery that measures patient reported satisfaction and quality of life (QOL) developed by Memorial Sloan Kettering Cancer Center. It is comprised of 10 scales that address: 1) psychosocial well-being, 2) sexual well-being, 3) satisfaction with breasts, 4) physical well-being, 5) adverse effects of radiation, 6) satisfaction with information - breast surgeon, 7) satisfaction with information - radiation oncologist, 8) satisfaction with surgeon, 9) satisfaction with medical team, 10) satisfaction with office staff. Each module is scored from 0-100 where higher scores reflect a better outcome.
Measured: After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start18 Feb 2022
- Primary completion9 Dec 2025
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irada Ibrahim-zada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irada Ibrahim-zada, University of Kentucky
- Investigators
- Irada Ibrahim-zada, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150652
- Sponsor's protocol ID
- MCC-21-BRE-54
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
PubMed 36410913
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05150652
- Acronym / sponsor ID
- MCC-21-BRE-54
- Keywords
- Neoadjuvant endocrine therapy, Early stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Irada Ibrahim-zadaUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 9 Dec 2021 (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 study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Endocrine Therapy | Experimental | Drug: Anastrozole 1mg, Drug: Letrozole 2.5mg, Drug: Exemestane 25 mg, Drug: TamoxifenParticipants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed invasive breast cancer, clinically stage I-II.
- Clinically lymph node negative
- Eligible for anti-endocrine treatment (per medical oncologist)
- Postmenopausal women
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (7 listed)
- Progesterone receptor negativity
- High grade tumor
- Synchronous non-breast malignancy
- Receiving any other investigational agents that could impact the efficacy of this trial regimen
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
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 |
|---|---|---|
| Anastrozole 1mgAlso: ArimidexParticipants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days. | Drug | Neoadjuvant Endocrine Therapy |
| Letrozole 2.5mgAlso: FemaraParticipants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days. | Drug | Neoadjuvant Endocrine Therapy |
| Exemestane 25 mgAlso: AromasinParticipants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days. | Drug | Neoadjuvant Endocrine Therapy |
| TamoxifenAlso: SoltamoxParticipants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days. | Drug | Neoadjuvant Endocrine Therapy |
Primary outcome
Change in margin status
Time frame: Baseline, 6-months after neoadjuvant treatment and surgery
Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.
3 secondary outcomes
Residual cancer burden
Time frame: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Pattern of response
Time frame: After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Change in satisfaction with cosmetic outcome
Time frame: After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
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 31 Aug 2026.
- Derived from this study: PubMed 36410913McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
- Individual participant dataSharing planned: No
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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.
Irada Ibrahim-zada, MD principal investigator
University of Kentucky
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 Anastrozole 1mg, Letrozole 2.5mg and Exemestane 25 mg in people with Breast Cancer and HER2-negative Breast Cancer, run by Irada Ibrahim-zada 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 5 inclusion and 7 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 31 Aug 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?
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?
Change in margin status (time frame: Baseline, 6-months after neoadjuvant treatment and surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150652, which also lists 1 linked publication.
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 31 Aug 2026.