Breast CancerPhase 2NCT07054190
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
A Phase 2 study testing Inavolisib, Ribociclib and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 37 sites in 7 countries.
Trial summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inavolisib, Ribociclib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 9 Sep 2025to 28 Sep 2027
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
- Documented Ki-67 score >=5% as per local assessment
- Confirmed PIK3CA mutation
Who cannot join
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive BC
- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Trial locations and contacts
37 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
37 sites in 7 countries
Germany8 sites, 8 recruiting
- Recruiting
Das Brustzentrum
Berlin, 12623
- Recruiting
HELIOS Klinikum Berlin-Buch
Berlin, 13125
- Recruiting
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
- Recruiting
Kliniken Essen-Mitte
Essen, 45136
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
- Recruiting
Philipps-Universität Marburg
Marburg, 35043
- Recruiting
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, 33098
- Recruiting
HELIOS Klinikum Schwerin
Schwerin, 19055
Spain7 sites, 7 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
- Recruiting
Hospital Clinic Barcelona
Barcelona, 08036
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
United States6 sites, 6 recruiting
- Recruiting
Texas Oncology - Central South
Austin, Texas, 78731
- Recruiting
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
- Recruiting
West Cancer Center
Germantown, Tennessee, 38138
- Recruiting
Los Angeles Cancer Network
Los Angeles, California, 90017-4803
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
- Recruiting
Community Clinical Trials
Orange, California, 92868
Canada5 sites, 5 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C2
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T1E2
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
- Recruiting
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Brazil4 sites, 4 recruiting
- Recruiting
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
- Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
- Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
- Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-000
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center.
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Aleman de Buenos Aires
Buenos Aires, C1118AAT
- Recruiting
Centro Médico Fleischer
Buenos Aires, C1414DRK
- Recruiting
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
About this study
Official title: A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
- Conditions
- Breast Cancer
- Being tested
- Inavolisib, Ribociclib, Letrozole, Giredestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InavolisibDrug
Also called GDC-0077, RO7113755
Inavolisib will be administered as per the schedule specified in the arms
RibociclibDrug
Ribociclib will be administered as per the schedule specified in the arms
LetrozoleDrug
Letrozole will be administered as per the schedule specified in the arms
GiredestrantDrug
Giredestrant will be administered as per the schedule specified in the arms
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Letrozole |
| Arm B | Experimental | Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Letrozole |
| Arm C | Experimental | Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Letrozole |
| Arm D (non-randomized) | Experimental | Participants will receive inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Letrozole |
| Arm E | Experimental | Participants will receive inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Giredestrant |
| Arm F | Experimental | Participants will receive a starting regimen of inavolisib and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Giredestrant |
| Arm G | Experimental | Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). Receives: Drug: Inavolisib; Drug: Ribociclib; Drug: Giredestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: From first dose up to 30 days after last dose (approximately 8 months)
Secondary outcomes (7)
Percentage of Participants with Total Pathological Complete Response (pCR)
Measured: Up to approximately 8 months
Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)
Measured: Up to approximately 8 months
Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)
Measured: Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days
Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Measured: Up to approximately 8 months
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Measured: Up to approximately 8 months
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Measured: Baseline, up to approximately 8 months
Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item
Measured: Baseline, up to approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start9 Sep 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054190
- Sponsor's protocol ID
- BO45853
- Other IDs
- 2024-518811-20-00
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
- ClinicalTrials.gov ID
- NCT07054190
- Acronym / sponsor ID
- BO45853
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 8 Jul 2025 (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.
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: LetrozoleParticipants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm B | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: LetrozoleParticipants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm C | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: LetrozoleParticipants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm D (non-randomized) | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: LetrozoleParticipants will receive inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm E | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: GiredestrantParticipants will receive inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm F | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: GiredestrantParticipants will receive a starting regimen of inavolisib and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). |
| Arm G | Experimental | Drug: Inavolisib, Drug: Ribociclib, Drug: GiredestrantParticipants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
Key exclusion criteria (6 listed)
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive BC
- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
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 |
|---|---|---|
| InavolisibAlso: GDC-0077, RO7113755Inavolisib will be administered as per the schedule specified in the arms | Drug | Arm A, Arm B, Arm C, Arm D (non-randomized), Arm E, Arm F, Arm G |
| RibociclibRibociclib will be administered as per the schedule specified in the arms | Drug | Arm A, Arm B, Arm C, Arm D (non-randomized), Arm E, Arm F, Arm G |
| LetrozoleLetrozole will be administered as per the schedule specified in the arms | Drug | Arm A, Arm B, Arm C, Arm D (non-randomized) |
| GiredestrantGiredestrant will be administered as per the schedule specified in the arms | Drug | Arm E, Arm F, Arm G |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: From first dose up to 30 days after last dose (approximately 8 months)
7 secondary outcomes
Percentage of Participants with Total Pathological Complete Response (pCR)
Time frame: Up to approximately 8 months
Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)
Time frame: Up to approximately 8 months
Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)
Time frame: Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days
Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Time frame: Up to approximately 8 months
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time frame: Up to approximately 8 months
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline, up to approximately 8 months
Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item
Time frame: Baseline, up to approximately 8 months
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 26 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
Reference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inavolisib, Ribociclib and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 37 sites in 7 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 7 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 26 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 37 sites in Germany, Spain, United States, Canada, Brazil and 2 more countries. 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?
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 Reference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: From first dose up to 30 days after last dose (approximately 8 months)). 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 26 Oct 2026.