Invasive Lobular Breast CarcinomaPhase 2ROSALINENCT04551495
Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)
A Phase 2 study testing Entrectinib, Letrozole and Goserelin in people with Invasive Lobular Breast Carcinoma and ER+ Breast Cancer, run by Jules Bordet Institute at 10 sites in 2 countries.
Trial summary
Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Lobular Breast Carcinoma, ER+ Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- Entrectinib, Letrozole and Goserelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 14 Jan 2021to Jan 2025
- Phase
- Phase 2
- 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
- Female
- Age ≥ 18 years
- Histological diagnosis of invasive lobular breast adenocarcinoma that is ER+, and HER2- as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested foci are lobular, ER+ and HER2-.
- ER positive (ER+ is defined as having an IHC of 1% or more and/or an Allred of 3 or more and HER2-).
- HER2 negative as defined by 2018 ASCO / CAP Guidelines
Show all 23Show fewer
- A primary non metastatic or locally advanced tumour of 15 mm or more, cN0 or cN1 without prior treatment candidate for preoperative treatment.
- ECOG Performance Status (PS) 0 or 1.
- Adequate Bone Marrow Function including:
- Absolute Neutrophil Count (ANC) ≥1500/μL or ≥1.5x109/L;
- Platelets ≥100000/μL or ≥100 x 109/L;
- Haemoglobin ≥ 9 g/dL.
- Adequate Renal Function including:
- o Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
- Adequate Liver Function, including all of the following parameters:
- Total serum bilirubin ≤ 2.0 x ULN unless the subject has documented Gilbert syndrome
- Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 3 x ULN;
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Completion of all necessary screening procedures within 28 days prior to enrolment. Biopsies at screening must have been obtained up to max 6 weeks before the beginning of treatment.
- Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.
- Women who are not postmenopausal or have not undergone hysterectomy must have documented negative pregnancy test (serum) within 28 days prior to enrolment.
- Women of childbearing potential and their partners, who are sexually active, must agree to use one highly effective form of contraception (see protocol section 6.6.1) from the signing of the ICF until at least 5 weeks after last administration of entrectinib, or they must totally/truly abstain from any form of sexual intercourse. Use of oral hormonal contraceptive agents in this study is not permitted.
- Subject is affiliated to the French Social Security System.
Who cannot join
- Clinical T4 disease including inflammatory breast cancer and/or cN3.
- Prior history of invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated.
- Known hypersensitivity to the study drugs or excipients.
- Hyperuricemia > Grade 1
- Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements.
- Subjects unable to swallow oral medications.
Show all 17Show fewer
- Prior intake of letrozole, any ROS1 inhibitor, any TRK inhibitor or anticancer therapy (including endocrine therapy). Ovarian suppression including prior administration of a LHRH analogue (i.e. goserelin) is allowed prior to cycle 1 day 1, at the discretion of the investigator.
- Concurrent treatment with strong or moderate CYP3A inhibitor.
- Concurrent treatment with any of the drugs not permitted, i.e. strong CYP3A inducers and drugs known to cause QTc interval prolongation.
- Significant cardiac disease, including recent (less than 6 months) myocardial infarction, congestive heart failure, unstable angina, and bradyarrhythmias.
- LVEF ≤ 55% measured by echo or MUGA
- QTc exceeding 450 msec, history of prolonged QTc interval prolongation; risk factors for torsade de pointes; other concomitant medications that may prolong QTc; family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
- Pregnant or lactating women.
- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
- Peripheral neuropathy ≥ Grade 2
- Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption.
- Vulnerable persons according to the article L.1121-6 of the CSP, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Belgium7 sites
Institut Jules Bordet
Brussels, 1070
UZ Brussel
Brussels, 1090
UCL Saint-Luc
Brussels, 1200
Grand Hôpital de Charleroi
Charleroi, 6000
UZ Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
CHU Namur - Sainte Elisabeth
Namur, 5000
France3 sites
Institut Bergonié
Bordeaux, 33076
Institut Curie
Paris, 75248
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast
Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.
Read the detailed description
The neoadjuvant setting has been the target of increasing interest recently, as it offers the possibility of direct evaluation of treatment effect on tumour size, better surgical results as well as for the possible research opportunities it provides via the comparative analysis of tumour biology and clinical outcomes before and after treatment.
Invasive lobular breast cancer (ILBC) is the second most common histologic subtype (5-15%) after invasive ductal breast cancer (IDBC). Despite clinical and pathologic differences, ILBC is still treated as IDBC. Indeed, subjects with ILBC tend to have lower response rates to conventional chemotherapeutic agents and some results have suggested that they might derive increased benefit with aromatase inhibitors.
CDK4/6 inhibitors in combination with endocrine therapy are FDA-approved for the treatment of ER-positive/HER2-negative metastatic breast cancer following the results of 7 positive phase 3 trials. These agents are currently tested in phase 3 studies in the adjuvant setting and might achieve the status of standard of care for subjects with ER-positive/HER2-negative early breast cancer treated with curative intent. In the NeoPAL (UCBG10/4, NCT02400567) neoadjuvant randomized study, Residual Cancer Burden (RCB) 0-1 status was achieved for 7.7% of subjects in the letrozole + palbociclib arm. This rate is not available for the 7 subjects with lobular breast cancer enrolled in this arm.
In lobular breast cancer, loss of E-cadherin (CDH1) expression is the most frequent oncogenic event and is present in 90% of cases. In vitro, ex vivo, and in vivo model systems as well as different functional profiling modalities (genetic and chemical screens) have been used to identify CDH1 synthetic lethality interactions. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. A study is currently investigating this hypothesis in ER+/HER2- metastatic lobular breast cancer (NCT03620643).
Entrectinib is a potent small-molecule tyrosine kinase inhibitor that targets oncogenic rearrangements in NTRK, ROS1, and ALK. In vitro, entrectinib potently ROS1 at low nanomolar concentrations, with an average median inhibitory concentration of 0.007 μM against ROS1.
This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER-positive/HER2-negative early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib. Subjects will receive four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women will receive goserelin 3.6 mg every 28 days.
Subjects' response to therapy will be evaluated at screening, after 2 cycles and after the 4 cycles of treatment by breast magnetic resonance imaging (MRI). An ECG will be performed at screening and then before cycle 2. Surgery will take place after at least 16 weeks of treatment, during week 18 (+ 7-day window). Breast and axillary surgery will follow local practice.
Post-operative therapy will be at the discretion of the investigator and will follow local practice.
- Being tested
- Entrectinib, Letrozole, Goserelin
- Medical subject headings
- Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrectinibDrug
Entrectinib is administered orally at a dose of 600 mg once a day from days 1 to 28 of a 28-day cycle for four cycles
LetrozoleDrug
Letrozole is administered orally at a dose of 2.5 mg once a day from days 1 to day 28 of a 28 day cycle for four cycles
GoserelinDrug
Goserelin is administered subcutaneously at a dose of 3.6 mg at the beginning of each cycle for 4 monthly cycles to pre-menopausal women
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Subjects will receive four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women will receive goserelin 3.6 mg every 28 days. Receives: Drug: Entrectinib; Drug: Letrozole; Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of endocrine therapy + entrectinib in women with ER+/HER2- early breast cancer of the lobular subtype:Residual Cancer Burden (RCB)
Residual Cancer Burden (RCB) 0/1 by local evaluation in all enrolled subjects.
Measured: At surgery
Secondary outcomes (1)
Evaluation of the efficacy of the combination by pathology: Pathologic complete response (pCR) rate
Pathologic complete response (pCR) rate in breast and axilla (ypT0/Tis ypN0) by local evaluation
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start14 Jan 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Lobular Breast CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, muti-center, phase 2 trial
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Philippe Aftimos, MD, Study chair, Jules Bordet Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551495
- Sponsor's protocol ID
- IJB-LOB-2019
- Acronym
- ROSALINE
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agostinetto E, Nader-Marta G, Paesmans M, Ameye L, Veys I, Buisseret L, Neven P, Taylor D, Fontaine C, Duhoux FP, Canon JL, Denys H, Coussy F, Chakiba C, Ribeiro JM, Piccart M, Desmedt C, Ignatiadis M, Aftimos P. ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast. Future Oncol. 2022 Jul;18(22):2383-2392. doi: 10.2217/fon-2022-0358. Epub 2022 Jun 13.
PubMed 35695563Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.
PubMed 35119530
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast
- ClinicalTrials.gov ID
- NCT04551495
- Acronym / sponsor ID
- ROSALINE / IJB-LOB-2019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 16 Sep 2020 (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.
Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.
Detailed description
The neoadjuvant setting has been the target of increasing interest recently, as it offers the possibility of direct evaluation of treatment effect on tumour size, better surgical results as well as for the possible research opportunities it provides via the comparative analysis of tumour biology and clinical outcomes before and after treatment.
Invasive lobular breast cancer (ILBC) is the second most common histologic subtype (5-15%) after invasive ductal breast cancer (IDBC). Despite clinical and pathologic differences, ILBC is still treated as IDBC. Indeed, subjects with ILBC tend to have lower response rates to conventional chemotherapeutic agents and some results have suggested that they might derive increased benefit with aromatase inhibitors.
CDK4/6 inhibitors in combination with endocrine therapy are FDA-approved for the treatment of ER-positive/HER2-negative metastatic breast cancer following the results of 7 positive phase 3 trials. These agents are currently tested in phase 3 studies in the adjuvant setting and might achieve the status of standard of care for subjects with ER-positive/HER2-negative early breast cancer treated with curative intent. In the NeoPAL (UCBG10/4, NCT02400567) neoadjuvant randomized study, Residual Cancer Burden (RCB) 0-1 status was achieved for 7.7% of subjects in the letrozole + palbociclib arm. This rate is not available for the 7 subjects with lobular breast cancer enrolled in this arm.
In lobular breast cancer, loss of E-cadherin (CDH1) expression is the most frequent oncogenic event and is present in 90% of cases. In vitro, ex vivo, and in vivo model systems as well as different functional profiling modalities (genetic and chemical screens) have been used to identify CDH1 synthetic lethality interactions. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. A study is currently investigating this hypothesis in ER+/HER2- metastatic lobular breast cancer (NCT03620643).
Entrectinib is a potent small-molecule tyrosine kinase inhibitor that targets oncogenic rearrangements in NTRK, ROS1, and ALK. In vitro, entrectinib potently ROS1 at low nanomolar concentrations, with an average median inhibitory concentration of 0.007 μM against ROS1.
This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER-positive/HER2-negative early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib. Subjects will receive four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women will receive goserelin 3.6 mg every 28 days.
Subjects' response to therapy will be evaluated at screening, after 2 cycles and after the 4 cycles of treatment by breast magnetic resonance imaging (MRI). An ECG will be performed at screening and then before cycle 2. Surgery will take place after at least 16 weeks of treatment, during week 18 (+ 7-day window). Breast and axillary surgery will follow local practice.
Post-operative therapy will be at the discretion of the investigator and will follow local practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, muti-center, phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Entrectinib, Drug: Letrozole, Drug: GoserelinSubjects will receive four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women will receive goserelin 3.6 mg every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Female
- Age ≥ 18 years
- Histological diagnosis of invasive lobular breast adenocarcinoma that is ER+, and HER2- as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested foci are lobular, ER+ and HER2-.
- A primary non metastatic or locally advanced tumour of 15 mm or more, cN0 or cN1 without prior treatment candidate for preoperative treatment.
Key exclusion criteria (17 listed)
- Clinical T4 disease including inflammatory breast cancer and/or cN3.
- Prior history of invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated.
- Known hypersensitivity to the study drugs or excipients.
- Hyperuricemia > Grade 1
- Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements.
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 |
|---|---|---|
| EntrectinibEntrectinib is administered orally at a dose of 600 mg once a day from days 1 to 28 of a 28-day cycle for four cycles | Drug | Single Arm |
| LetrozoleLetrozole is administered orally at a dose of 2.5 mg once a day from days 1 to day 28 of a 28 day cycle for four cycles | Drug | Single Arm |
| GoserelinGoserelin is administered subcutaneously at a dose of 3.6 mg at the beginning of each cycle for 4 monthly cycles to pre-menopausal women | Drug | Single Arm |
Primary outcome
Evaluation of the efficacy of endocrine therapy + entrectinib in women with ER+/HER2- early breast cancer of the lobular subtype:Residual Cancer Burden (RCB)
Time frame: At surgery
Residual Cancer Burden (RCB) 0/1 by local evaluation in all enrolled subjects.
1 secondary outcome
Evaluation of the efficacy of the combination by pathology: Pathologic complete response (pCR) rate
Time frame: At surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 35695563Agostinetto E, Nader-Marta G, Paesmans M, Ameye L, Veys I, Buisseret L, Neven P, Taylor D, Fontaine C, Duhoux FP, Canon JL, Denys H, Coussy F, Chakiba C, Ribeiro JM, Piccart M, Desmedt C, Ignatiadis M, Aftimos P. ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast. Future Oncol. 2022 Jul;18(22):2383-2392. doi: 10.2217/fon-2022-0358. Epub 2022 Jun 13.
- Derived from this study: PubMed 35119530Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Philippe Aftimos, MD study chair
Jules Bordet Insitute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entrectinib, Letrozole and Goserelin in people with Invasive Lobular Breast Carcinoma and ER+ Breast Cancer, run by Jules Bordet Institute at 10 sites in 2 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 23 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, France. 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?
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?
Evaluation of the efficacy of endocrine therapy + entrectinib in women with ER+/HER2- early breast cancer of the lobular subtype:Residual Cancer Burden (RCB) (time frame: At surgery). 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 NCT04551495, which also lists 2 linked publications.
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 Dec 2024.