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Hormonal Receptor (HR)-positive HER2 negative breast cancer patients treated with preoperative ELacestrant and PULSAR adaptive radiotherapy: a phase II study
EU CTIS ID: 2025-520762-22-00
What this study is testing
To assess safety and tolerability of PULSAR preoperative radiation therapy and Elacestrant
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients able to understand and follow instructions during the trial.
- Patients with tumor accessible for biopsy and surgery
- Patients with adequate bone marrow function at Screening, confirmed at Baseline, including: a. ANC ≥ 1.5 × 109/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109/L, with ANC ≥ 1.0 × 109/L, leukocytes ≥ 4.0 × 109/L, and lymphocytes ≥ 0.6 × 109/L; b. platelets ≥ 100 × 109/L; c. hemoglobin ≥ 9 g/dL (may have been transfused);
- International Normalized Ratio (INR) < 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR < 3.
- Patients with adequate hepatic function at Screening, confirmed at Baseline, defined by a. total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN; b. aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN, or, for patients with documented metastatic disease to the liver, AST and ALT levels ≤5×ULN.
- Measurable primary breast lesion ≥20mm at baseline breast MRI
You likely can't join if
- Patients with a history of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator’s judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of the PULSAR or Elacestrant or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.
- Patients who underwent prior organ transplantation, including allogeneic stem cell transplantation.
- Patients with history of uncontrolled intercurrent illness, including but not limited to uncontrolled hypertension (high blood pressure defined as BPD>=140 mmHg or BPS >=90 mmHg despite of combination therapy with diuretic/CCB/ACE or ARB).
- Patients with active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).
- Patients with a known prior hypersensitivity or contraindications to any of the IMPs or any component in its formulations or any other drug scheduled or likely to be given during the trial
- Patients with severe acute or chronic medical conditions, including a. Immune colitis b. Inflammatory bowel disease c. History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline d. Immune pneumonitis e. Pulmonary fibrosis f. Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior g. Laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.
See the full eligibility criteria
Who can join
- Patients able to understand and follow instructions during the trial.
- Patients with tumor accessible for biopsy and surgery
- Patients with adequate bone marrow function at Screening, confirmed at Baseline, including: a. ANC ≥ 1.5 × 109/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109/L, with ANC ≥ 1.0 × 109/L, leukocytes ≥ 4.0 × 109/L, and lymphocytes ≥ 0.6 × 109/L; b. platelets ≥ 100 × 109/L; c. hemoglobin ≥ 9 g/dL (may have been transfused);
- International Normalized Ratio (INR) < 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR < 3.
- Patients with adequate hepatic function at Screening, confirmed at Baseline, defined by a. total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN; b. aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN, or, for patients with documented metastatic disease to the liver, AST and ALT levels ≤5×ULN.
- Measurable primary breast lesion ≥20mm at baseline breast MRI
- Patients with adequate renal function at Screening, confirmed at Baseline, defined by eGFR ≥ 30 mL/min using 2021 CKD-EPI creatinine equation.
- Patients must be able to undergo CT/PET scan and MRI/Ultrasound imaging procedures for tumor diagnosis and follow-up.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of at least 12 months according to the Investigator’s judgement.
- Patients able and willing to give written informed consent, signed and dated.
- Post-menopausal female and male patients.
- Patients aged at least 18 years old at the time of ICF signature.
- Any N-positive (stage II-III) HR+ HER2- breast cancer patients diagnosed as candidates for neoadjuvant chemotherapy
What rules you out
- Patients with a history of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator’s judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of the PULSAR or Elacestrant or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.
- Patients who underwent prior organ transplantation, including allogeneic stem cell transplantation.
- Patients with history of uncontrolled intercurrent illness, including but not limited to uncontrolled hypertension (high blood pressure defined as BPD>=140 mmHg or BPS >=90 mmHg despite of combination therapy with diuretic/CCB/ACE or ARB).
- Patients with active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).
- Patients with a known prior hypersensitivity or contraindications to any of the IMPs or any component in its formulations or any other drug scheduled or likely to be given during the trial
- Patients with severe acute or chronic medical conditions, including a. Immune colitis b. Inflammatory bowel disease c. History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline d. Immune pneumonitis e. Pulmonary fibrosis f. Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior g. Laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.
- Patients with a history of small intestine resection surgery or other major gastrointestinal surgery that would preclude adequate absorption, distribution, metabolism, or excretion of Elacestrant.
- Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive).
- Patients with increased anesthesiological risk (e.g. known or predicted difficult airway) if general anesthetic is required.
- Patients with increased bleeding risk (e.g. coagulopathies) and patients on anticoagulants.
- Premenopausal state (defined as any woman who is not surgically sterile with a hysterectomy and/or bilateral oophorectomy or ≥ 12 months of amenorrhea and at least 50 years of age)
- Patients receiving any other treatment that, in the opinion of the Investigator, might interfere with the trial.
- Patients who previously received Elacestrant or breast radiotherapy.
- Patients participating in any other clinical trial within 30 days before Screening.
- Patients with a current drug or substance abuse.
- Patients with any significant co-morbidity which, according to the Investigator’s judgement, makes patient compliance to trial conditions unlikely.
- Patients unable to understand the Protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
- Patients who are unlikely to comply with the Protocol requirements, instructions and trialrelated restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.
- Patients with legal incapacity or limited legal capacity.
- Patients with any condition which results in an undue risk for the patient during the trial participation according to the Investigator.
- Patients with previous malignant disease (other than the tumor disease for this trial) within the last five (5) years (except adequately treated non-melanoma skin cancers and carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least two (2) years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.