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Breast Cancer PatientsPhase 2HELPNCT07005882

Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy

A Phase 2 study testing Elacestrant and PULSAR in people with Breast Cancer Patients and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR. The study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Elacestrant and PULSAR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteItaly
Study dates
1 Sep 2025to 1 Mar 2028
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven HR-positive, HER2-negative BC
  • Clinical disease stage II-III
  • Post-menopausal female patients or male patients
  • Eligible for neoadjuvant treatment and subsequent surgery
  • No contraindication to MRI
  • Patient able to understand and follow instructions during the trial
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  • Patient able and willing to give written informed consent, signed and dated
  • Patient aged at least 50 years old
  • Patient with tumor accessible for biopsy and surgery
  • Patient with adequate bone marrow function at Screening, confirmed at Baseline, including:
  • 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;
  • platelets ≥ 100 × 109/L;
  • 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
  • Patient with adequate hepatic function at Screening, confirmed at Baseline, defined by:
  • total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN; aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN,
  • Patient with adequate renal function at Screening, confirmed at Baseline, defined by eGFR ≥ 30 mL/min using 2021 CKD-EPI creatinine equation
  • Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Life expectancy of at least 12 months according to the Investigator's judgement

Who cannot join

  • 1. Patients with stage IV disease 2. 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 RT and/or Elacestrant or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.
  • 3. Patients with any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.
  • 4. 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.
  • 5. Patients with a history of uncontrolled intercurrent illness. 6. Patients with a known prior hypersensitivity or contraindications to Elacestrant or any component in its formulations.
  • 7. Patients with severe acute or chronic medical conditions, including:
  • Immune colitis
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  • Inflammatory bowel disease
  • History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline
  • Immune pneumonitis
  • Pulmonary fibrosis
  • Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior
  • 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.
  • 8. Patients with a history of small intestine resection surgery or other major gastrointestinal surgery.
  • 9. Patients with an active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).
  • 10. Patients with a known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug-resistant gram-negative bacteria.
  • 11. 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).
  • 12. Patients with increased anesthesiological risk (e.g. known or predicted difficult airway) if general anesthetic is required.
  • 13. Premenopausal patients (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) 14. Patients aged less than 50 years old. 15. Patients with a known history of drug/substance abuse. 16. Patients participating in any other clinical trial within 30 days before Screening.
  • 17. Patients receiving any other treatment that, in the opinion of the Investigator, might interfere with the trial.
  • 18. Concomitant use of strong or moderate CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.
  • 19. Concomitant use of strong or moderate CYP3A4 inducers should be avoided and an alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered.
  • 20. Patients with a current drug or substance abuse. 21. Patients receiving chronic concurrent therapy within two (2) weeks before the trial treatment or expected therapy during the trial treatment period with:
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  • Corticosteroids (except systemic corticosteroids up to 10 mg prednisolone or equivalent daily dose).
  • Immunosuppressive agents.
  • Antibiotics.
  • Any other anticancer therapy or concurrent anticancer treatment. 22. Patients who are unable to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
  • 23. Patients who are unlikely to comply with the Protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.
  • 24. Patients with legal incapacity or limited legal capacity. 25. Patients with any condition which results in an undue risk for the patient during the trial participation according to the Investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • AOU Careggi Radiation Oncology Unit

    Florence, 50134

    Lorenzo Livi, Prof., 0557947264 ext. +39, lorenzo.livi@unifi.it

Other trials in Italy

About this study

Official title: Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Adaptive Radiotherapy: a Phase II Study (HELP Trial)

This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.

The study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Patients will receive Elacestrant 345 mg orally once daily for 24 weeks and PULSAR on the MRI-based breast gross tumor volume (GTVt), consisting of 10 Gy "pulse" every 4 weeks for a maximum of 5 or less in case of radiologic complete response.

Surgery will be planned 24 weeks after Elacestrant initiation and at least 2 weeks from the last pulse and will be performed as per recommended clinical practice. Patients will then receive adjuvant systemic therapy as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if indicated.

Being tested
Elacestrant, PULSAR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Preoperative treatment

  • PULSARRadiation

    Preoperative treatment

Study groups in NCT07005882
Study groupRoleWhat they receive
Preoperative Elacestrant+PULSARExperimentalNot described
Receives: Drug: Elacestrant; Radiation: PULSAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of reported adverse events (AEs) and serious adverse events (SAEs), according to CTCAE v5.0.

    Evaluation of changes from Baseline during the Treatment and Follow-up periods.

    Measured: Baseline, every two weeks in the pre-operative period, 30 days and 3 months after surgery

  2. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • laboratory parameters: hematology (Hemoglobin, HMCV, MCH, MCHC, RBC, WBC with differential count, and platelet count); biochemistry (Sodium, potassium, calcium, chloride, glucose (fasting), anorganic phosphate, cholesterol, triglycerides, total protein, uric acid, urea, creatinine, total bilirubin, alkaline phosphatase, ALT, AST, gamma-GT, LDH, CPK, amylase, and lipase); coagulation (PT, INR and activated partial thromboplastin time); and urinalysis (Leukocytes, nitrite, pH, protein, glucose, ketone, urobilinogen, bilirubin, hemoglobin, erythrocytes, specific gravity.).

    These values will be used to assess the patient's health status and the presence of any adverse events that may have arisen after therapy.

    Measured: Baseline, every two weeks unitl week 4, then every 4 weeks in the pre-operative period, 30 days and 3 months after surgery

  3. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • physical examinations: (i.e. ECOG PS 0-5).

    Measured: Baseline, every two weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

  4. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • vital signs: temperature in °C

    Measured: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

  5. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • electrocardiograms: heart rate, PR/PQ interval, QRS interval, QT interval.

    Measured: Baseline, at the beginning (week 0) and at the end (week 20) of pre-operative treatment.

  6. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • vital signs: heart rate in beats/min (bpm).

    Measured: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

  7. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • vital signs: blood pressure in mmHg.

    Measured: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

  8. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • vital signs: respiratory frequency in breaths/min.

    Measured: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

  9. Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting

    Evaluation of changes from Baseline during the Treatment and Follow-up periods in:

    • vital signs: SpO2 in %.

    Measured: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005882
Sponsor's protocol ID
HELP Trial
Other IDs
2025-520762-22-00, 2025
Acronym
HELP
Status last verified
Mar 2025
First submitted
25 Mar 2025
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacestrant and PULSAR in people with Breast Cancer Patients and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.

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 19 inclusion and 29 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: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting (time frame: Baseline, every two weeks in the pre-operative period, 30 days and 3 months after surgery). The study lists 9 primary outcomes in all. 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 NCT07005882.

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 5 Jun 2025.

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