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Could a Four-Times-a-Year shot replace daily pills for breast cancer?

NCT ID NCT07401381

Disease control Sponsor: Rovi Pharmaceuticals Laboratories Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests whether a new quarterly injection of letrozole delivers the same amount of medicine into the body as the standard daily pill. It involves 120 postmenopausal women who have already completed at least 4-5 years of hormone therapy for early breast cancer. The goal is to see if the injection can offer a more convenient dosing option while maintaining similar drug levels and safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women with weight of ≥50 kg and a Body Mass Index (BMI) ≥19 kg/m2 and ≤39 kg/m2 * Postmenopausal women. * Women with confirmed diagnosis of HR+/HER2- or HR+/HER2+ early stage breast cancer who have completed at least 5 years of endocrine therapy, at least 2 years of which were with letrozole. Participants at a low risk of relapse, as assessed by the investigator, can also be eligible after completing 4 years of adjuvant endocrine therapy, at least 2 of which were with letrozole. * Women in good health. * Women who have undergone breast imaging per applicable guidelines (e.g., mammogram) within the last 12 months with no evidence of malignancy (documentation required), and if not done, must be willing to have 1 performed prior to baseline. Exclusion Criteria: * Presence of an uncontrolled, unstable, clinically significant medical condition. * Have used estrogen or progesterone systemic or topical therapy, oral contraceptives, androgens, LH-releasing hormone analogs, prolactin inhibitors, or antiandrogens within 3 months prior to screening. * Use of inducers or inhibitors of CYP3A4 and CYP2A6. * Diagnosed with osteoporosis. * Preexisting cardiovascular disease * Positive result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibodies.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hormone receptor positive early breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Althaia Xarxa Assistencial Universitària de Manresa F.P (Investigational Site number ESP-012)

    RECRUITING

    Manresa, 08243, Spain

  • Complejo Asistencial Universitario de León - Hospital de León (Investigational Site number ESP-013)

    RECRUITING

    León, 24071, Spain

  • Consorci Corporació Sanitària Parc Taulí - Hospital de Sabadell (Investigational Site number ESP-006)

    RECRUITING

    Sabadell, 08208, Spain

  • D&H National Research Centers INC (Investigational Site number USA-002)

    RECRUITING

    Margate, Florida, 33063, United States

  • Hospital Clinico Universitario Santiago de Compostela (Investigational Site number ESP-007)

    RECRUITING

    Santiago de Compostela, 15705, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009)

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Quirónsalud Málaga (Investigational Site number ESP-001)

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Universitario Arnau de Vilanova de Lleida (Investigational Site number ESP-003)

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015)

    RECRUITING

    Alcorcón, 28922, Spain

  • Hospital Universitario Virgen de las Nieves (Investigational Site number ESP-011)

    RECRUITING

    Granada, 18014, Spain

  • Investigational Site number SRB-001

    RECRUITING

    Kamenitz, 21204, Serbia

  • Investigational Site number SRB-002

    RECRUITING

    Belgrade, 11080, Serbia

  • Investigational Site number SRB-003

    RECRUITING

    Kragujevac, 34000, Serbia

  • Investigational Site number SRB-004

    RECRUITING

    Belgrade, 11000, Serbia

  • Investigational Site number SRB-005

    RECRUITING

    Niš, 18000, Serbia

  • NEXT Oncology Phase I Unit - Hospital Universitario Quironsalud Madrid (Investigational Site number ESP-008)

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona (Investigational Site number ESP-002)

    RECRUITING

    Barcelona, 08023, Spain

  • Precision NextGen Oncology and Research Center (Investigational Site number USA-001)

    RECRUITING

    Beverly Hills, California, 90212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.