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Anatomic Stage I Breast Cancer AJCC v8Phase 4NCT05183828

Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer

A Phase 4 study testing Biospecimen Collection, Letrozole and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor therapy such as letrozole. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Letrozole and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
23 Jan 2022to 13 May 2026
Phase
Phase 4
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be female age >= 18 years.
  • Postmenopausal as defined by at least one of the following:
  • Age >= 60 years;
  • Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females;
  • Documented bilateral oophorectomy.
  • Histologically confirmed diagnosis of carcinoma of the breast, clinical stage I-III.
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  • Minimum tumor diameter of 1.0 cm as assessed by palpation or imaging (e.g., ultrasound) and with enough tumor left after the initial diagnostic biopsy to provide tumor tissue during the planned tumor resection.
  • Candidate for surgical resection.
  • ER+ breast cancer (> 1% positive stained cells) based on the most recent tumor biopsy documented by a local laboratory or medical record.
  • Ki67 >= 10%.
  • HER2-negative 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.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin) if discontinued > 6 months prior to diagnosis. Vaginal preparations are allowed.
  • Ability to take oral medication and be willing to adhere to the study intervention.

Who cannot join

  • Pre-treatment tumor biopsy sample not likely to provide adequate tissue sections for biomarker assays.
  • Inoperable or metastatic disease.
  • Subjects who have received any prior therapy for breast cancer, including radiotherapy, surgery, and cytotoxic and endocrine treatments.
  • The subject must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 1 year prior to study enrollment. (Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the study intervention period.
  • Subjects with plans to undergo neoadjuvant chemotherapy.
  • Use of hormonal contraceptives within 6 months of diagnosis.
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  • Treatment with another investigational drug or other intervention within 28 days before the first administration of letrozole.
  • History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to letrozole or any ingredients.
  • Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Association of HSD3B1 Genotype With Response to Preoperative Letrozole Therapy Among Postmenopausal Women With Estrogen-Receptor Positive (ER+) HER2/Neu-Negative (HER2-) Invasive Carcinomas of the Breast

This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor therapy such as letrozole. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

OUTLINE:

Patients receive letrozole orally (PO) once daily (QD) for 21 days in the absence of disease progression or unacceptable toxicity. If tumor resection occurs before or after day 22, letrozole administration must occur for a minimum of 14 days and a maximum of 70 days of total treatment. Patients also undergo collection of saliva samples.

Being tested
Biospecimen Collection, Letrozole, Questionnaire Administration
Medical subject headings
Carcinoma, Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of saliva samples

  • LetrozoleDrug

    Also called CGS 20267, Femara

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05183828
Study groupRoleWhat they receive
Treatment (letrozole)ExperimentalPatients receive letrozole PO QD for 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of saliva samples. If tumor resection occurs before or after day 22, letrozole administration must occur for a minimum of 14 days and a maximum of 70 days of total treatment.
Receives: Procedure: Biospecimen Collection; Drug: Letrozole; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Ki67

    Will be assessed according to germline status.

    Measured: Before (baseline) and up to 9 months after surgery

  2. Changes in Ki67

    Will be assessed according to somatic HSD3B1 (1245C) variant status.

    Measured: Before (baseline) and up to 9 months after surgery

  3. Changes in estrogen receptor (ER)alpha

    Will be assessed according to germline status.

    Measured: Before (baseline) and up to 9 months after surgery

  4. Changes in estrogen receptor (ER)alpha

    Will be assessed according to somatic HSD3B1 (1245C) variant status.

    Measured: Before (baseline) and up to 9 months after surgery

  5. Changes in ER beta

    Will be assessed according to germline status.

    Measured: Before (baseline) and up to 9 months after surgery

  6. Changes in ER beta

    Will be assessed according to somatic HSD3B1 (1245C) variant status.

    Measured: Before (baseline) and up to 9 months after surgery

  7. Effect of HSD3B1 (1245C) variant on changes in Ki67

    Will evaluate whether androgen receptor (AR)+ modifies the effect of HSD3B1 (1245C) variant on changes in Ki67 before and after preoperative letrozole treatment, and whether this effects ER- and AR- gene expression signatures.

    Measured: Before (baseline) and up to 9 months after surgery

  8. Expression of 3betaHSD1

    Will compare expression of 3betaHSD1 according to HSD3B1 allele status.

    Measured: Up to 9 months after surgery

  9. Expression of intracellular androgen

    Will compare expression of intracellular androgen according to HSD3B1 allele status.

    Measured: Up to 9 months after surgery

  10. Expression of estrogen levels

    Will compare expression of estrogen levels according to HSD3B1 allele status.

    Measured: Up to 9 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start23 Jan 2022
  3. Primary completion13 May 2026
  4. Study completion13 May 2026

Why it stopped: Study ended earlier than anticipated due to end of funding.

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183828
Sponsor's protocol ID
RG1121659
Other IDs
NCI-2021-12428, IR10794, P30CA015704
Status last verified
Jun 2026
First submitted
9 Dec 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biospecimen Collection, Letrozole and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington 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 14 inclusion and 9 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 4 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: Study ended earlier than anticipated due to end of funding.). Results are not available in the source record.

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?

Changes in Ki67 (time frame: Before (baseline) and up to 9 months after surgery). The study lists 10 primary outcomes in all. 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 NCT05183828.

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 4 Jun 2026.

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