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Back|NCT05846789Recruiting
Official Title

A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

Phase
Phase 2
Sponsor
Kathy Miller
Enrollment
168
Timeline
Jul 2024 → Dec 2026
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1≥ 18 years old at the time of informed consent
  • 2Ability to provide written informed consent and HIPAA authorization
  • 3Locally 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)
  • 4Received up to 2 prior therapies for metastatic disease
  • 5Prior (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.
  • 6Participation in this protocol as either first, second and third-line therapy is allowed.
  • 7Planned standard of care chemotherapy based on NCCN guidelines.
  • 8Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.
  • 9Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents.
  • 10Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.
  • 11Patients 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.
  • 12Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting.
  • 13PD-L1 status is not required for patients in the second line setting.
  • 14Measurable disease based on RECIST 1.1 criteria.
  • 15Disease amenable to and consent for study-specific biopsy NOTE: If no disease amenable to biopsy is present at the time of second biopsy, subjects may continue participation in the study and further study specific biopsies will not be required.
  • 16ECOG PS 0 or 1
  • 17Patients 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 stable or decreasing dose of corticosteroids. Brain MRI or head CT is required at screening for patients with known brain metastases.
  • 18Adequate organ function as indicated by:
  • 19Total bilirubin \< ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL)
  • 20Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 x ULN
  • 21Creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula
  • 22Absolute neutrophil count (ANC) \> 1.2 K/mm3
  • 23Platelets \> 75 K/ mm3
  • 24Hgb \> 9.0 g/dL
  • 25Women 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 tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
  • 26Has undergone a hysterectomy or bilateral oophorectomy; or
  • 27Has been naturally amenorrheic for at least 24 consecutive months.
  • 28Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment.
  • 29NOTE: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).

Exclusion Criteria

  • 1Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent
  • 2Active infection requiring parenteral antibiotics
  • 3Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
  • 4Active or symptomatic CNS disease
  • 5Patients 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 gene copies per cell.
  • 6Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded
  • 7Radiation therapy within 2 weeks of registration
  • 8Hormone therapy within 2 weeks of registration
  • 9Planned treatment with Olaparib or other PARP inhibitor.

Locations

5 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Shipra Gandhi, MD

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana 46032

Recruiting

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

Recruiting

Kathy Miller, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →