RECRUITING

SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers

Conditions

Metastatic Breast Cancer Triple Negative Breast Cancer Estrogen-receptor-low Breast Cancer Breast Cancer Phase II

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-02

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05846789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. Zero or one prior chemotherapy for metastatic disease 5. Planned standard of care chemotherapy based on NCCN guidelines. 1. Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed. 2. Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents. 6. Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting. 1. 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. 2. Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting. 3. PD-L1 status is not required for patients in the second line setting. 7. Measurable disease based on RECIST 1.1 criteria. 8. Disease 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. 9. ECOG PS 0 or 1 10. 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 stable or decreasing dose of corticosteroids. Brain MRI or head CT is required at screening for patients with known brain metastases. 11. 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) \> 1.2 K/mm3 5. Platelets \> 75 K/ mm3 6. Hgb \> 9.0 g/dL 12. 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. 13. Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment.	1. Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent 2. Active infection requiring parenteral antibiotics 3. Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement 4. Active or symptomatic CNS disease 5. 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 gene copies per cell. 6. Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded 7. Radiation therapy within 2 weeks of registration 8. Hormone therapy within 2 weeks of registration 9. Planned treatment with Olaparib or other PARP inhibitor.

Inclusion Criteria

Exclusion 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. Zero or one prior chemotherapy for metastatic disease
5. Planned standard of care chemotherapy based on NCCN guidelines.
1. Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.
2. Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents.
6. Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.
1. 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.
2. Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting.
3. PD-L1 status is not required for patients in the second line setting.
7. Measurable disease based on RECIST 1.1 criteria.
8. Disease 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.
9. ECOG PS 0 or 1
10. 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 stable or decreasing dose of corticosteroids. Brain MRI or head CT is required at screening for patients with known brain metastases.
11. 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) \> 1.2 K/mm3
5. Platelets \> 75 K/ mm3
6. Hgb \> 9.0 g/dL
12. 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.
13. Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment.

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

Contacts and Locations

Study Contact

Xin Bryan, RN

CONTACT

317-274-5495

zhongx@iupui.edu

Principal Investigator

Kathy Miller, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

Collaborators and Investigators

Sponsor: Kathy Miller

Kathy Miller, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Phase II

Additional Relevant MeSH Terms

Metastatic Breast Cancer
Triple Negative Breast Cancer
Estrogen-receptor-low Breast Cancer