Breast CancerEarly Phase 1ELIPSENCT04797728
Elacestrant in Preoperative Setting, a Window of Opportunity Study
A Early Phase 1 study testing Elacestrant in people with Breast Cancer and Hormone Receptor Positive Breast Carcinoma, run by SOLTI Breast Cancer Research Group at 4 sites in Spain.
Trial summary
ELIPSE is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of Elacestrant on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early 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, Hormone Receptor Positive Breast Carcinoma
- What is being tested?
- Elacestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesSpain
- Study dates
- 9 Feb 2021to 25 Feb 2022
- Phase
- Early Phase 1
- 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
- Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Postmenopausal women defined either by:
- Age ≥60,
- Age < 60 and amenorrhea for ≥ 12 months and FSH and E2 plasmatic levels in the post-menopausal range per local standards or
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- Prior bilateral oophorectomy (≥ 30 days before Day 1 of the study treatment).
- Histologically confirmed invasive breast carcinoma eligible for surgery with all the following characteristics:
- Primary tumor diameter of at least 15 mm (cT1c-3) as measured by breast US.
- No regional lymph node metastases by imaging or clinical examination (cN0).
- ER+ tumors, irrespective of PgR status, (nuclear stain >1%) as assessed locally, defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) clinical practice guidelines.
- HER2-negative status, as assessed locally, defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP)
- In case of multifocal tumors (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be measured in at least one dimension of minimal 15 mm per US. This lesion will be designated as 'target' lesion for all subsequent evaluations. ER+ and HER2-negative status must be documented in all the tumor foci if they are independent of the target lesion (does not apply to small tumoral foci around the main lesion).
- Cells staining positive for Ki67 ≥ 10% as locally assessed.
- Available pre-treatment formalin-fixed paraffin-embedded (FFPE) tumor specimen or possibility to obtain one. Minimal sample requirements are: at least 2 tumor cylinders with a minimal tissue surface of 10 mm2, containing ≥10% tumor cells, enough to obtain at least 2 cuts of 10 μm each. Tumor cylinder will be mandatory.
- No clinical or radiographic evidence of distant metastases (M0).
- Adequate hematologic and organ function within 14 days before the first study treatment on Day 1, defined by the following:
- Neutrophils (ANC ≥1500/μL).
- Hemoglobin ≥9 g/dL (with no need for transfusions).
- Platelet count ≥100000/μL.
- Serum albumin ≥3 g/dL.
- Calculated creatinine clearance of ≥60 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation:
- (140 - age) x (weight in kg) x 0.85 72 x (serum creatinine in mg/dL)
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) within therapeutic range. History of deep thrombotic episodes or pulmonary embolism, or incremental risk for thrombosis at investigator criteria.
- Potassium, total Calcium (corrected for serum albumin), and Sodium with institutional normal limits or corrected with normal limits with supplement before first dose of study medication.
- Ability to swallow study drug and comply with study requirements.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Who cannot join
- Inoperable locally advanced or inflammatory breast cancer.
- Metastatic (Stage IV) breast cancer.
- Synchronous invasive bilateral or multicentric breast cancer.
- Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.
- Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment.
- Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin cancer, in situ cervical cancer or adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years.
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- Congenital long QT syndrome or screening QT interval corrected using Fridericia's formula (QTcF) > 480 milliseconds or any clinically significant cardiac rhythm abnormalities.
- Liver function tests documented within the screening period and on Day 1 of treatment period:
- Total bilirubin >1.5x the upper limit of normal unless the patient has documented non-malignant disease (e.g. Gilbert´s syndrome) for whom conjugated bilirubin must be under ULN.
- AST and ALT >2.5x ULN.
- Alkaline phosphatase ALP >2x ULN.
- Concurrent, serious, uncontrolled infections or current known infection with HIV (testing is not mandatory).
- Known hypersensitivity to any of the study drugs, including excipients.
- History or clinical evidence of any liver or biliary pathology including cirrhosis, infectious disease, inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis, primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincter of Oddi, biliary cyst or biliary atresia).
- Known clinically significant history active viral or other hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV] antibody at screening), current drug or alcohol abuse, or cirrhosis.
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [HBcAg] antibody test) are eligible.
- Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy. The following corticosteroid uses are permitted: single doses, topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local injections (e.g. intra-articular).
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to swallow pills.
- History of or clinical evidence of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent.
- Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration or plans to start any other investigational product or device study within 30 days after last drug administration.
- Previous hormonal treatments for other indications such as osteoporosis, breast cancer prevention, hormonal substitutive therapy, such as raloxifen, tamoxifen, estrogen, progestins must have ended at least 24 months prior to trial registration. If a patient is on natural products known to contain progestins, they must be stopped 14 days prior to beginning study treatment.
- Used any prescription medication during the prior 1 month that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating.
- Major surgical procedure or significant traumatic injury within 30 days prior to enrollment.
- Patients with thromboembolic risks.
- Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
ICO Badalona
Badalona, Barcelona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic Barcelona
Barcelona, 08036
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
ELIPSE is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of Elacestrant on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early breast cancer (BC) amenable to surgery.
Read the detailed description
The main hypothesis is that Elacestrant induces a significant proliferative arrest (Ki67 ≤ 2.7%) in ER+ and HER2-negative BC naïve to Endocrine Therapy (ET). To test this hypothesis, a total of 24 patients will be recruited.
Secondary objectives will include correlative molecular and histological analyses at the tumor tissue, changes in Ki67 and the identification of molecular biomarkers and gene signatures of response to Elacestrant. Molecular analysis of tumor circulating DNA (ctDNA) in blood will be also performed.
The study population consists of postmenopausal women with cT1c-3 (minimal 15 mm of largest diameter) cN0 cM0, ER+ and HER2-negative breast operable tumors.
Patients who fulfil all eligibility criteria will then start treatment in Elacestrant monotherapy cohort as follows: Elacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD). After 4 weeks (+/- 2 days) of Elacestrant treatment, surgery will be performed in accordance to local practice. If the tumor is not surgically removed after 4 weeks (+/-3 days), a tumor biopsy will be obtained. In this case, patients may continue further neoadjuvant treatment under physicians' criteria.
Two biopsies of the same lesion will be mandatory: first the screening sample and second the surgical sample. A core biopsy will be collected if surgery is not performed for any reason. Complete Cell Cycle Arrest (CCCA) (determined by Ki67 ≤ 2.7%) and relative changes in the PAM50 subtypes in tumor samples will be analyzed at baseline and after 4-weeks of Elacestrant therapy at central laboratory. Ki67 status at baseline will be performed at local sites for inclusion criteria (Ki67 at diagnostic ≥10%). Extensive RNA-based and blood analyses will be performed in tumor specimens at the same timepoints.
Safety assessments will include the incidence, nature, and severity of Adverse Events (AEs) and laboratory abnormalities graded per the NCI CTCAE v.5.0
- Being tested
- Elacestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Elacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD) for 4 weeks (+/- 2 days)
| Study group | Role | What they receive |
|---|---|---|
| Elacestrant | Experimental | 400 mg given orally (PO), once a day, in a continuous schedule (QD). 4 weeks (+/- 2 days) of elacestrant treatment Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cell Cycle Arrest
Ki67 ≤ 2.7%
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Secondary outcomes (9)
PAM50 (Prediction Analysis of Microarray 50) subtype change
PAM50 subtype changes upon elacestrant therapy
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Gene expression change (post-treatment/pre-treatment)
Differential expression (mean suppression = 100 - [geometric mean (post-treatment / pre-treatment · 100)]) of 11 proliferative genes from PAM50 (BIRC5, CCNB1, CDC20, CDCA1, CEP55, KNTC2, MKI67, PTTG1, RRM2, TYMS and UBE2C).
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Adverse Events
Frequency and severity of adverse events (evaluated according to CTCAE v.5.0.) and frequency of interruptions due to treatment toxicity.
Measured: Until End of Study Visit (7-28 days after surgery)
Global gene expression changes
Relative changes of expression 770 genes across of 23 categories of BC tumor biology after 4 weeks of treatment. This study will be performed using the Nanostring nCounter Breast 360TM panel
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Gene expression-based signature of response
To derive a new gene expression-based signature of response to Elacestrant.
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Celularity/Tumor Infiltrating Lymphocytes (CelTIL) score
CelTIL score = -0.8 × tumor cellularity (in %) + 1.3 × TILs (in %). The minimum and maximum unscaled CelTIL scores will be -80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points. TILs determination will be quantified according to the 2014 Guidelines developed by the International TILs Working Group
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Mean change in Ki67
Mean change in Ki67 values per central assessment before and after therapy and its 95% confidence interval (CI).
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Changes in the distribution of somatic mutations
To identify changes in the distribution of somatic mutations (e.g. PIK3CA, ESR1) between basal and surgery samples
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
ctDNA (post-treatment/pre-treatment)
Quantification of ctDNA (post-treatment/pre-treatment)
Measured: After 4 weeks (+/- 2 days) of elacestrant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start9 Feb 2021
- Primary completion8 Feb 2022
- Study completion25 Feb 2022
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Radius Health, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797728
- Sponsor's protocol ID
- ELIPSE (SOLTI-1905)
- Acronym
- ELIPSE
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elacestrant in Preoperative Setting, a Window of Opportunity Study
- ClinicalTrials.gov ID
- NCT04797728
- Acronym / sponsor ID
- ELIPSE / ELIPSE (SOLTI-1905)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Radius Health, Inc.
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 15 Mar 2021 (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.
ELIPSE is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of Elacestrant on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early breast cancer (BC) amenable to surgery.
Detailed description
The main hypothesis is that Elacestrant induces a significant proliferative arrest (Ki67 ≤ 2.7%) in ER+ and HER2-negative BC naïve to Endocrine Therapy (ET). To test this hypothesis, a total of 24 patients will be recruited.
Secondary objectives will include correlative molecular and histological analyses at the tumor tissue, changes in Ki67 and the identification of molecular biomarkers and gene signatures of response to Elacestrant. Molecular analysis of tumor circulating DNA (ctDNA) in blood will be also performed.
The study population consists of postmenopausal women with cT1c-3 (minimal 15 mm of largest diameter) cN0 cM0, ER+ and HER2-negative breast operable tumors.
Patients who fulfil all eligibility criteria will then start treatment in Elacestrant monotherapy cohort as follows: Elacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD). After 4 weeks (+/- 2 days) of Elacestrant treatment, surgery will be performed in accordance to local practice. If the tumor is not surgically removed after 4 weeks (+/-3 days), a tumor biopsy will be obtained. In this case, patients may continue further neoadjuvant treatment under physicians' criteria.
Two biopsies of the same lesion will be mandatory: first the screening sample and second the surgical sample. A core biopsy will be collected if surgery is not performed for any reason. Complete Cell Cycle Arrest (CCCA) (determined by Ki67 ≤ 2.7%) and relative changes in the PAM50 subtypes in tumor samples will be analyzed at baseline and after 4-weeks of Elacestrant therapy at central laboratory. Ki67 status at baseline will be performed at local sites for inclusion criteria (Ki67 at diagnostic ≥10%). Extensive RNA-based and blood analyses will be performed in tumor specimens at the same timepoints.
Safety assessments will include the incidence, nature, and severity of Adverse Events (AEs) and laboratory abnormalities graded per the NCI CTCAE v.5.0
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elacestrant | Experimental | Drug: Elacestrant400 mg given orally (PO), once a day, in a continuous schedule (QD). 4 weeks (+/- 2 days) of elacestrant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Postmenopausal women defined either by:
- Histologically confirmed invasive breast carcinoma eligible for surgery with all the following characteristics:
Key exclusion criteria (26 listed)
- Inoperable locally advanced or inflammatory breast cancer.
- Metastatic (Stage IV) breast cancer.
- Synchronous invasive bilateral or multicentric breast cancer.
- Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.
- Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment.
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 |
|---|---|---|
| ElacestrantElacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD) for 4 weeks (+/- 2 days) | Drug | Elacestrant |
Primary outcome
Complete Cell Cycle Arrest
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Ki67 ≤ 2.7%
9 secondary outcomes
PAM50 (Prediction Analysis of Microarray 50) subtype change
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Gene expression change (post-treatment/pre-treatment)
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Adverse Events
Time frame: Until End of Study Visit (7-28 days after surgery)
Global gene expression changes
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Gene expression-based signature of response
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Celularity/Tumor Infiltrating Lymphocytes (CelTIL) score
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Mean change in Ki67
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Changes in the distribution of somatic mutations
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
ctDNA (post-treatment/pre-treatment)
Time frame: After 4 weeks (+/- 2 days) of elacestrant therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Elacestrant in people with Breast Cancer and Hormone Receptor Positive Breast Carcinoma, run by SOLTI Breast Cancer Research Group at 4 sites in Spain.
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 27 inclusion and 26 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: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete Cell Cycle Arrest (time frame: After 4 weeks (+/- 2 days) of elacestrant therapy). 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 2022.