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New treatment option for Metastatic Breast Cancer
Official title SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
ClinicalTrials.gov ID: NCT05846789
What this study is testing
What is SOC Chemotherapy?
SOC Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-low (ER and PR ≤ 9%...
- Received up to 2 prior therapies for metastatic disease
- Prior (neo)adjuvant therapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of...
You likely can't join if
- Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent
- Active infection requiring parenteral antibiotics
- Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
- Active or symptomatic CNS disease
- Patients with HER2+ disease Note: HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a...
- Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be...
See the full eligibility criteria
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-low (ER and PR ≤ 9% weak staining)
- Received up to 2 prior therapies for metastatic disease
- Prior (neo)adjuvant therapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of completion of (neo)adjuvant therapy.
- Participation in this protocol as either first, second and third-line therapy is allowed.
- Planned standard of care chemotherapy based on NCCN guidelines.
- Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.
- Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents.
- Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.
- Patients who received (neo)adjuvant IO therapy and progress while on or within 12 months of completion of (neo)adjuvant IO therapy may participate without additional IO treatment.
- Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting.
- PD-L1 status is not required for patients in the second line setting.
- Measurable disease based on RECIST 1.1 criteria.
- ECOG PS 0 or 1
- Patients with treated, asymptomatic CNS disease may participate if the patient is \> 4 weeks from completion of CNS therapy (radiation and/or surgery), is clinically stable at the time of study entry, and is receiving...
- Adequate organ function as indicated by:
- Total bilirubin \< ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 x ULN
- Creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula
- Absolute neutrophil count (ANC) \> 1.2 K/mm3
- Platelets \> 75 K/ mm3
- Hgb \> 9.0 g/dL
- Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a...
- Has undergone a hysterectomy or bilateral oophorectomy; or
- Has been naturally amenorrheic for at least 24 consecutive months.
- Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment. NOTE: Acceptable methods of birth control include abstinence...
- Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent
- Active infection requiring parenteral antibiotics
- Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
- Active or symptomatic CNS disease
- Patients with HER2+ disease Note: HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \> 2.0 or \> 6 total HER2...
- Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded
- Radiation therapy within 2 weeks of registration
- Hormone therapy within 2 weeks of registration
- Planned treatment with Olaparib or other PARP inhibitor.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
- Buffalo, New York, United States
- Durham, North Carolina, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Carmel, Indiana, United States; Indianapolis, Indiana, United States; Buffalo, New York, United States; Durham, North Carolina, United States. 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 ClinicalTrials.gov; the study team decides eligibility.