Phase II Trial of Carboplatin +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

K
Kathy Miller, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase 2
168 participants needed
3 Locations

Brief description of study

What is the purpose of this study?
This is a randomized Phase II study of carboplatin monotherapy vs. carboplatin combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • Patients are stratified by either Black or non-Black (race-based cohort) and are then randomized 1:1 to either the monotherapy or combination arm. 
  • This requires 42 patients (21 per treatment arm) in stage I for each race-based cohort. 
  • If the no. of response in experimental - no. of response in control is no greater than -1, the trial is early stopped at stage I for futility. Otherwise, additional 42 patients for each race-based cohort will be enrolled and randomized to the study in stage II for a total of 168 subjects across all 4 arms.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:
  1. ≥ 18 years old at the time of informed consent
  2. Ability to provide written informed consent and HIPAA authorization
  3. 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)
  4. No prior chemotherapy for metastatic disease
    1. Prior (neo)adjuvant therapy must have been completed at least 12 months from diagnosis of unresectable locally recurrent or metastatic disease.
  5. Measurable disease based on RECIST 1.1 criteria.
  6. Disease amenable to and consent for study-specific biopsy
    1. 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.
  7. ECOG PS 0 or 1
  8. 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 a stable or decreasing dose of corticosteroid therapy. Brain MRI or head CT is required at screening for patients with known brain metastases.
  9. Adequate organ function as indicated by:
    1. Total bilirubin < ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5.0 x ULN
    3. Creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
    4. Absolute neutrophil count (ANC) > 1.5 K/mm3
    5. Platelets > 100 K/ mm3
    6. Hgb > 9.0 g/dL
  10. 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 tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
    1. Has undergone a hysterectomy or bilateral oophorectomy; or
    2. Has been naturally amenorrheic for at least 24 consecutive months.
  11. 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, 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:
          1. Prior treatment with or known contraindication to treatment with tocilizumab or other
             IL-6/IL-6R targeted agent
          2. Patients who are PD-L1 positive (CPS ≥ 10), unless they have a clear contraindication
             to pembrolizumab therapy.
          3. Active infection requiring parenteral antibiotics
          4. Concurrent use of methotrexate or systemic corticosteroids
          5. Active or symptomatic CNS disease
          6. Patients with HER2+ disease 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.
          7. Patients with active malignancy other than breast cancer. Patients with prior
             malignancies without recurrence after standard treatment will not be excluded
          8. Radiation therapy within 2 weeks of registration
          9. Hormone therapy within 2 weeks of registration

Updated on 13 Dec 2024. Study ID: CTO-IUSCCC-0817, 18668
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