Elacestrant in Preoperative Setting, a Window of Opportunity Study

NCT04797728 | Completed Early Phase 1 FDA Drug

• 1 other identifier: ELIPSE (SOLTI-1905)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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) amenable to surgery.

Conditions

Breast Cancer; Hormone Receptor Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Cell Cycle Arrest

  Ki67 ≤ 2.7%

  After 4 weeks (+/- 2 days) of elacestrant therapy

Secondary Outcomes (9)

• PAM50 (Prediction Analysis of Microarray 50) subtype change

  After 4 weeks (+/- 2 days) of elacestrant therapy

• Gene expression change (post-treatment/pre-treatment)

  After 4 weeks (+/- 2 days) of elacestrant therapy

• Adverse Events

  Until End of Study Visit (7-28 days after surgery)

• Global gene expression changes

  After 4 weeks (+/- 2 days) of elacestrant therapy

• Gene expression-based signature of response

  After 4 weeks (+/- 2 days) of elacestrant therapy

Study Arms (1)

Elacestrant

EXPERIMENTAL

400 mg given orally (PO), once a day, in a continuous schedule (QD). 4 weeks (+/- 2 days) of elacestrant treatment

Drug: Elacestrant

Interventions

Elacestrant DRUG

Elacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD) for 4 weeks (+/- 2 days)

Elacestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead
• Radius Health, Inc.: collaborator

Study Sites (4)

ICO Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

elacestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 15, 2021
• Study Start: February 9, 2021
• Primary Completion: February 8, 2022
• Study Completion: February 25, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

ES (4)