Hormone Receptor Positive Early Breast CancerPhase 1SIE-1NCT07401381
A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer
A Phase 1 study testing US-sourced oral Femara® + Letrozole SIE and EU sourced oral Femara® + Letrozole SIE in people with Hormone Receptor Positive Early Breast Cancer, run by Rovi Pharmaceuticals Laboratories at 21 sites in 3 countries.
Trial summary
The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hormone Receptor Positive Early Breast Cancer
- What is being tested?
- US-sourced oral Femara® + Letrozole SIE and EU sourced oral Femara® + Letrozole SIE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 8 Jun 2026to Oct 2028
- Phase
- Phase 1
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 3 countries
Spain13 sites, 13 recruiting
- Recruiting
Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015)
Alcorcón, 28922
- Recruiting
NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona (Investigational Site number ESP-002)
Barcelona, 08023
- Recruiting
Hospital Universitario Virgen de las Nieves (Investigational Site number ESP-011)
Granada, 18014
- Recruiting
Hospital Universitario de Jaén (HUJ) (Investigational Site number ESP-005)
Jaén, 23007
- Recruiting
Complejo Asistencial Universitario de León - Hospital de León (Investigational Site number ESP-013)
León, 24071
- Recruiting
Hospital Universitario Arnau de Vilanova de Lleida (Investigational Site number ESP-003)
Lleida, 25198
- Recruiting
Hospital Quirónsalud Málaga (Investigational Site number ESP-001)
Málaga, 29004
- Recruiting
Althaia Xarxa Assistencial Universitària de Manresa F.P (Investigational Site number ESP-012)
Manresa, 08243
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009)
Murcia, 30120
- Recruiting
NEXT Oncology Phase I Unit - Hospital Universitario Quironsalud Madrid (Investigational Site number ESP-008)
Pozuelo de Alarcón, 28223
- Recruiting
Hospital Universitari Sant Joan de Reus (Investigational Site number ESP-004)
Reus, 43204
- Recruiting
Consorci Corporació Sanitària Parc Taulí - Hospital de Sabadell (Investigational Site number ESP-006)
Sabadell, 08208
- Recruiting
Hospital Clinico Universitario Santiago de Compostela (Investigational Site number ESP-007)
Santiago de Compostela, 15705
Serbia5 sites, 5 recruiting
- Recruiting
Investigational Site number SRB-004
Belgrade, 11000
- Recruiting
Investigational Site number SRB-002
Belgrade, 11080
- Recruiting
Investigational Site number SRB-001
Kamenitz, 21204
- Recruiting
Investigational Site number SRB-003
Kragujevac, 34000
- Recruiting
Investigational Site number SRB-005
Niš, 18000
United States3 sites, 3 recruiting
- Recruiting
Precision NextGen Oncology and Research Center (Investigational Site number USA-001)
Beverly Hills, California, 90212
- Recruiting
D&H National Research Centers INC (Investigational Site number USA-002)
Margate, Florida, 33063
- Recruiting
United Medical Research (Investigational Site number USA-005)
Port Orange, Florida, 32127
About this study
Official title: An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Quarterly Letrozole SIE and Once Daily 2.5 mg Oral Letrozole (Femara®) in Post-Menopausal Women Treated With Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer. (SIE-1)
The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone receptor-positive early breast cancer. Participants must have completed at least five years of hormone therapy with at least two of those years with letrozole before starting their participation in the study. Women who have completed four years of hormone therapy are also eligible if their doctor considers them at low risk of cancer returning.
Read the detailed description
The primary objective of the study is to evaluate the steady-state comparative bioavailability of quarterly injectable Letrozole SIE compared to United States (US)-sourced oral Femara® in the US-sourced arm and of quarterly injectable Letrozole SIE compared to European Union (EU)-sourced oral Femara® in the EU-sourced arm, in post-menopausal women treated with endocrine therapy for hormone-receptor positive (HR+) early breast cancer (EBC). The study also aims to characterize the elimination phase of Letrozole SIE after multiple doses.
The study consists of four periods: Screening, Treatment Period 1 (TP1), Treatment Period 2 (TP2) and Extension Period. After the Screening Period, participants will be randomized to two different arms: US-sourced oral Femara® or EU-sourced oral Femara® for 14 days to achieve the steady-state concentrations of letrozole in TP1. After receiving the latest oral letrozole dose, participants from both arms will start TP2. In TP2, quarterly injectable Letrozole SIE will be administered to achieve steady-state. After TP2, a subset of participants (up to 60 participants, regardless of which study arm they belong to) will continue in the study for the assessment of the elimination phase of Letrozole SIE after multiple doses during the Extension Period.
It is estimated that approximately 120 subjects should be randomized.
- Being tested
- US-sourced oral Femara® + Letrozole SIE, EU sourced oral Femara® + Letrozole SIE
- Keywords
- Letrozole SIE, Early breast cancer, Pharmacokinetics, Bioavailability, Safety, Endocrine therapy, Injectable
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-sourced oral Femara® + Letrozole SIEDrug
US-sourced Femara® 2.5 mg/day oral for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)
EU sourced oral Femara® + Letrozole SIEDrug
EU-sourced oral Femara® 2.5 mg/day for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)
| Study group | Role | What they receive |
|---|---|---|
| US-sourced oral Femara® | Experimental | Not described Receives: Drug: US-sourced oral Femara® + Letrozole SIE |
| EU-sourced oral Femara® | Experimental | Not described Receives: Drug: EU sourced oral Femara® + Letrozole SIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau)
Individual and mean area under the concentration-time curve within a dosing interval at steady-state
Measured: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® on Day 14 TP1
Secondary outcomes (14)
Adverse Events
Incidence of adverse events (type, severity, seriousness, and relationship to study drug), including the incidence of treatment-emergent adverse events (TEAEs), the incidence of serious TEAEs, and the incidence of TEAEs leading to treatment discontinuation.
Measured: From the time of obtaining signed informed consent until the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)
Injection site reactions
Incidence of injection site reactions
Measured: At pre-dose and 1 hour after each Letrozole SIE administration in TP2
Injection-related pain score
Changes in injection-related pain score by numeric rating scale (NRS). The NRS evaluates the intensity of injection-related pain experienced at the time of Letrozole SIE administration. It is scored from 0 to 10 (0 meaning no pain and 10 meaning the worst possible pain).
Measured: From baseline TP2 to the follow-up visit on Day 281
Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA)
Changes in bone mineral density BMD by DXA
Measured: From screening to Day 281 TP2
Average plasma drug concentration during a dosing interval at Steady-State (SS Cave)
Individual and mean steady-state average plasma drug concentration during a dosing interval
Measured: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Minimum drug concentration at steady-state (Cmin ss)
Minimum drug concentration at steady-state
Measured: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Maximum plasma concentration at steady-state (Cmax ss)
Maximum plasma concentration at steady-state
Measured: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Letrozole blood level percent fluctuation
Individual and mean letrozole blood percent fluctuation
Measured: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Time to peak observed concentration (Tmax)
Time to peak observed concentration
Measured: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Steady-State (SS)
Characterization of the steady-state
Measured: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Terminal rate constant (λz)
Individual and mean Terminal rate constant (λz) after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
Measured: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Terminal half-life (t1/2)
Individual and mean Terminal half-life after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
Measured: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve extrapolated to infinity (AUC∞)
Individual and mean Area under the curve extrapolated to infinity after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
Measured: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve that is extrapolated (AUCextrap)
Percentage of area under the curve that is extrapolated after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
Measured: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start8 Jun 2026
- Primary completionMay 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 Hormone Receptor Positive Early 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401381
- Sponsor's protocol ID
- ROV-SIE-2025-01
- Other IDs
- 2025-523269-31-00, 2025
- Acronym
- SIE-1
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Quarterly Letrozole SIE and Once Daily 2.5 mg Oral Letrozole (Femara®) in Post-Menopausal Women Treated With Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer. (SIE-1)
- ClinicalTrials.gov ID
- NCT07401381
- Acronym / sponsor ID
- SIE-1 / ROV-SIE-2025-01
- Keywords
- Letrozole SIE, Early breast cancer, Pharmacokinetics, Bioavailability, Safety, Endocrine therapy, Injectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Feb 2026 (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 study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone receptor-positive early breast cancer. Participants must have completed at least five years of hormone therapy with at least two of those years with letrozole before starting their participation in the study. Women who have completed four years of hormone therapy are also eligible if their doctor considers them at low risk of cancer returning.
Detailed description
The primary objective of the study is to evaluate the steady-state comparative bioavailability of quarterly injectable Letrozole SIE compared to United States (US)-sourced oral Femara® in the US-sourced arm and of quarterly injectable Letrozole SIE compared to European Union (EU)-sourced oral Femara® in the EU-sourced arm, in post-menopausal women treated with endocrine therapy for hormone-receptor positive (HR+) early breast cancer (EBC). The study also aims to characterize the elimination phase of Letrozole SIE after multiple doses.
The study consists of four periods: Screening, Treatment Period 1 (TP1), Treatment Period 2 (TP2) and Extension Period. After the Screening Period, participants will be randomized to two different arms: US-sourced oral Femara® or EU-sourced oral Femara® for 14 days to achieve the steady-state concentrations of letrozole in TP1. After receiving the latest oral letrozole dose, participants from both arms will start TP2. In TP2, quarterly injectable Letrozole SIE will be administered to achieve steady-state. After TP2, a subset of participants (up to 60 participants, regardless of which study arm they belong to) will continue in the study for the assessment of the elimination phase of Letrozole SIE after multiple doses during the Extension Period.
It is estimated that approximately 120 subjects should be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-sourced oral Femara® | Experimental | Drug: US-sourced oral Femara® + Letrozole SIE |
| EU-sourced oral Femara® | Experimental | Drug: EU sourced oral Femara® + Letrozole SIE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| US-sourced oral Femara® + Letrozole SIEUS-sourced Femara® 2.5 mg/day oral for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2) | Drug | US-sourced oral Femara® |
| EU sourced oral Femara® + Letrozole SIEEU-sourced oral Femara® 2.5 mg/day for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2) | Drug | EU-sourced oral Femara® |
Primary outcome
Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau)
Time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® on Day 14 TP1
Individual and mean area under the concentration-time curve within a dosing interval at steady-state
14 secondary outcomes
Adverse Events
Time frame: From the time of obtaining signed informed consent until the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)
Injection site reactions
Time frame: At pre-dose and 1 hour after each Letrozole SIE administration in TP2
Injection-related pain score
Time frame: From baseline TP2 to the follow-up visit on Day 281
Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA)
Time frame: From screening to Day 281 TP2
Average plasma drug concentration during a dosing interval at Steady-State (SS Cave)
Time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Minimum drug concentration at steady-state (Cmin ss)
Time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Maximum plasma concentration at steady-state (Cmax ss)
Time frame: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Letrozole blood level percent fluctuation
Time frame: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Time to peak observed concentration (Tmax)
Time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Steady-State (SS)
Time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Terminal rate constant (λz)
Time frame: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Terminal half-life (t1/2)
Time frame: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve extrapolated to infinity (AUC∞)
Time frame: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve that is extrapolated (AUCextrap)
Time frame: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
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 9 Oct 2026.
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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.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing US-sourced oral Femara® + Letrozole SIE and EU sourced oral Femara® + Letrozole SIE in people with Hormone Receptor Positive Early Breast Cancer, run by Rovi Pharmaceuticals Laboratories at 21 sites in 3 countries.
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 6 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Serbia, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Operations. Laboratorios Farmacéuticos ROVI (+34913756230, departamento.medico@rovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau) (time frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® on Day 14 TP1). 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 9 Oct 2026.