Phase III · Now Enrolling
A new daily oral option
for premenopausal
breast cancer.
A clinical trial is enrolling premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer — studying a once-daily oral capsule at sites across the United States.
Currently enrolling at multiple US sites
About the Study
What this trial is, and who it is for
This is a Phase III, randomized clinical trial studying a once-daily oral capsule therapy in premenopausal women diagnosed with early-stage, estrogen receptor-positive (ER+), HER2-negative breast cancer. The trial is conducted at academic and community oncology sites across the United States.
Premenopausal women with ER+ breast cancer face a distinct hormonal environment — their ovaries continue producing estrogen, which can influence how hormone-sensitive tumors behave. This trial was designed specifically for that biology. All participants receive active treatment — there is no placebo group. Read on to check your eligibility and find a site near you.
- Phase III Trial Stage
- Once Daily Oral Capsule
- Multiple US Sites
- ER+/HER2− Premenopausal
Understanding the Science
What makes this trial different for premenopausal women?
Most breast cancer endocrine therapy studies have been designed around postmenopausal biology. Premenopausal women are biologically different: their ovaries are still active and estrogen levels are higher. This can affect how estrogen receptor-positive tumors respond to standard treatments.
The investigational therapy in this trial is a once-daily oral capsule studied specifically for this hormonal profile. It is taken by mouth — no infusions or injections. You would be assigned to one of two active treatment groups, and your care team would monitor you throughout.
If you have questions about how the therapy works, your site coordinator will walk you through all the details before any decision is made.
About clinical trials
- A clinical trial tests whether a new treatment is safe and effective before it becomes widely available
- Every trial must be reviewed and approved by an independent ethics board before it can enroll participants
- Participants receive close, structured monitoring from a dedicated medical team
- You can ask questions and take time to decide — there is no pressure to join
- Participation is completely voluntary; you can withdraw at any time without it affecting your regular care
Why Participate
What participating may mean for you
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Close, structured care
You receive regular check-ins and assessments from an oncology team experienced in premenopausal breast cancer — additional monitoring you may not otherwise receive.
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Access to an investigational therapy
Study participants may have access to the investigational oral therapy, and study-related visits and assessments are provided at no cost to you.
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Contribution to future care
What is learned from your participation may help improve treatment options for premenopausal women with breast cancer in the future.
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Specialist oncology team
Each site is led by breast oncology specialists who understand the specific challenges premenopausal patients face and can explain every aspect of the study.
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Time to decide
You will receive written information explaining the study in full. You have time to read it, talk it over with your family or doctor, and ask as many questions as you need.
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No obligation to continue
Participation is voluntary at every stage. You can leave the study at any time without it affecting your standard cancer care or your relationship with your doctor.
How It Works
What happens if you are interested
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Check your eligibility
Answer a few short questions to see whether you may meet the initial criteria. This takes about two minutes and carries no obligation.
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Connect with a study team
A coordinator at your nearest site will call to discuss the trial, answer your questions, and explain what participation involves.
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Formal screening and consent
Your medical team conducts a full evaluation. If eligible, you receive written study information and have time to review it before signing consent.
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Enroll and begin
You are assigned to a treatment group and begin the study under close medical supervision at a site near you.
Participation Criteria
Who can take part?
The list below is a general overview. Eligibility is confirmed by your medical team during formal screening — not by an online form.
You may qualify if you…
- Are premenopausal at the time of enrollment
- Have early-stage breast cancer (Stage I–III)
- Have estrogen receptor-positive (ER+) breast cancer
- Have HER2-negative breast cancer
- Have completed primary surgery for breast cancer
- Are able to take an oral medication daily
You may not qualify if you…
- Are postmenopausal or have had surgical menopause
- Have HER2-positive breast cancer
- Have metastatic (Stage IV) breast cancer
- Have received certain prior endocrine therapies for this cancer
- Have significant liver or kidney problems
- Are pregnant or planning to become pregnant during the trial
Not sure if you qualify?Answer a few short questions — no commitment required.
Where to Participate
Study locations across the United States
The trial is enrolling at academic medical centers and community oncology clinics nationwide. New sites are added regularly. If no site is near you, submit your eligibility check and a coordinator will follow up.
Contact us to find your nearest enrolling location.
- Northeast US
- Southeast US
- Midwest US
- Southwest US
- West Coast US
- Additional sites — enquire
Why Trust This Study
Conducted with care and independent oversight
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Independent ethics review
The trial is reviewed and approved by Institutional Review Boards at each participating site before any participant can enroll. These are independent bodies not affiliated with the sponsor.
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Designed for premenopausal patients
The protocol was built specifically around the biology of premenopausal women with ER+ breast cancer — not adapted from a postmenopausal study design.
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Ongoing safety monitoring
An independent Data Safety Monitoring Board reviews ongoing data. If a safety concern arises, the board has authority to pause or stop enrollment immediately.
Common Questions
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study done with people to test whether a new medical treatment is safe and effective. Every trial must pass strict ethical review before it can run, and participants are monitored closely by a dedicated medical team throughout.
Who is conducting this breast cancer trial?
The trial is sponsored by Harbora Clinical Research and run at academic medical centers and community oncology clinics across the United States. Each site is led by a principal investigator who is an experienced breast oncologist.
What treatment is being studied?
An investigational once-daily oral capsule of an endocrine therapy developed for premenopausal women with ER+, HER2-negative early-stage breast cancer. Detailed information — including how it works and what is known about its safety — is explained to you during the consent process, before you decide to join.
Is there a placebo — will everyone receive active treatment?
All participants receive active treatment. The trial compares two active treatment regimens. There is no placebo-only group in this study.
I think I may be approaching menopause. Can I still apply?
Your menopausal status is confirmed by blood tests and a full medical evaluation at screening — not just by your history or how you feel. If you are unsure, we encourage you to apply and allow the clinical team to make that determination.
How long does participation last?
Duration is defined by the trial protocol and may depend on your individual response. Your study coordinator will walk you through the full expected schedule — including clinic visits and follow-up — before you make any decision to enroll.
What if there is no study site near me?
New sites are opening regularly. Submit your eligibility check and a coordinator will get in touch about upcoming sites in your region, or discuss any available support for travel.
Who decides whether I can participate?
The site’s principal investigator and medical team make that determination during formal screening, based on criteria including cancer stage, hormone receptor status, menopausal status, and overall health — not on an online questionnaire alone.
Take the first step
See if you may qualify
A short eligibility check is all it takes to get started. No commitment, no pressure — just information to help you decide.
Participation is entirely voluntary. A member of the study team will explain all risks and answer your questions before any decision is made.