BridgeMD
A study to test the effect of Samuraciclib in Combination with Elacestrant in Participants with Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-) breast cancer
EU CTIS ID: 2023-503846-30-00
What this study is testing
Phase 1b (Dose Finding): Determine the recommended Phase 2 dose (RP2D) of samuraciclib and elacestrant in combination. Phase 2 (Expansion): To assess the efficacy of samuraciclib and elacestrant in combination in terms of progression-free survival (PFS) as per local investigator assessment.
- Phase I and Phase II (Integrated)- Other
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
- Histologically confirmed diagnosis of carcinoma of the breast with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- Documentation of ER-positive with or without progesterone receptor (PgR)-positive tumor based on most recent tumor biopsy utilizing an assay consistent with local standards. • ER-positivity is defined as ≥10% positive stained cells regardless of the PgR-result (Hammond et al., 2010; Allison et al., 2020).
- Documentation of HER2 negativity based on local testing on most recent tumor biopsy. • HER2-negativity is defined as immunohistochemistry score 0/1+ or negative by in situ hybridization (fluorescent in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH] defined as a HER2/chromosome 17 FISH (CEP17) ratio <2 or for single probe assessment a HER2 copy number <4 • Biopsy of first recurrence is recommended, in case no tumor biopsy was performed after initial resection of the primary tumor, the original tumor tissue serves as basis for assessment of ER/PgR and HER2 status • Assessment of ER, PgR, and HER2 status will be based on results from local pathology laboratories.
- Must have 1 of the following as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: • Measurable disease • Bone only disease with evaluable lesions. Participants who have had prior radiation to bone must have at least 1 evaluable lesion in a nonirradiated area. For clarity bone lesions must be evaluable, but do not need to be measurable.
- Participants must have documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- Participants must have received an aromatase inhibitor in combination with a CDK4/6 inhibitor in one of the following settings: • Participants must have received at least 6 months of clinical benefit on this line of therapy to be eligible. Participants who received <6 months CDK4/6 inhibitor due to tolerability issues may still enter the study provided at least 6 months aromatase inhibitor was received. • Adjuvant setting, if the disease-free interval between initiation of endocrine therapy and first line treatment of locally advanced or metastatic disease was >24 months.
You likely can't join if
- Prior therapy with a Selective estrogen receptor degrader (SERD) or other investigational SERDs or alike agents in the advanced/metastatic setting.
- Prior treatment with cytotoxic chemotherapy for locally advanced or metastatic BC.
- Prior treatment with a mammalian target of rapamycin (mTOR) inhibitor including, but not limited to, everolimus.
- Inadequate hepatic, renal, bone marrow, or cardiac function, specified as follows: • Hepatic • Renal • Bone marrow • Cardiovascular
- Known central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of carcinoma of the breast with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- Documentation of ER-positive with or without progesterone receptor (PgR)-positive tumor based on most recent tumor biopsy utilizing an assay consistent with local standards. • ER-positivity is defined as ≥10% positive stained cells regardless of the PgR-result (Hammond et al., 2010; Allison et al., 2020).
- Documentation of HER2 negativity based on local testing on most recent tumor biopsy. • HER2-negativity is defined as immunohistochemistry score 0/1+ or negative by in situ hybridization (fluorescent in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH] defined as a HER2/chromosome 17 FISH (CEP17) ratio <2 or for single probe assessment a HER2 copy number <4 • Biopsy of first recurrence is recommended, in case no tumor biopsy was performed after initial resection of the primary tumor, the original tumor tissue serves as basis for assessment of ER/PgR and HER2 status • Assessment of ER, PgR, and HER2 status will be based on results from local pathology laboratories.
- Must have 1 of the following as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: • Measurable disease • Bone only disease with evaluable lesions. Participants who have had prior radiation to bone must have at least 1 evaluable lesion in a nonirradiated area. For clarity bone lesions must be evaluable, but do not need to be measurable.
- Participants must have documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- Participants must have received an aromatase inhibitor in combination with a CDK4/6 inhibitor in one of the following settings: • Participants must have received at least 6 months of clinical benefit on this line of therapy to be eligible. Participants who received <6 months CDK4/6 inhibitor due to tolerability issues may still enter the study provided at least 6 months aromatase inhibitor was received. • Adjuvant setting, if the disease-free interval between initiation of endocrine therapy and first line treatment of locally advanced or metastatic disease was >24 months.
- Expected life expectancy of greater than 12 weeks.
What rules you out
- Prior therapy with a Selective estrogen receptor degrader (SERD) or other investigational SERDs or alike agents in the advanced/metastatic setting.
- Prior treatment with cytotoxic chemotherapy for locally advanced or metastatic BC.
- Prior treatment with a mammalian target of rapamycin (mTOR) inhibitor including, but not limited to, everolimus.
- Inadequate hepatic, renal, bone marrow, or cardiac function, specified as follows: • Hepatic • Renal • Bone marrow • Cardiovascular
- Known central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment
- Inflammatory BC
- Prior treatment with a phosphatidylinositol-3-kinase (PI3K) inhibitor, including, but not limited to alpelisib.
- Prior treatment with an AKT (protein kinase B, or Akt) inhibitor, including, but not limited to capivasertib.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.