168 Participants Needed

Carboplatin +/- Tocilizumab for Breast Cancer

Recruiting at 3 trial locations
XB
Overseen ByXin Bryan, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use methotrexate or certain corticosteroids. Hormone therapy must be stopped at least 2 weeks before joining the trial.

What data supports the effectiveness of the drug Carboplatin in treating breast cancer?

Research shows that Carboplatin, when used in combination with other drugs like paclitaxel, has shown promising results in treating advanced breast cancer, with response rates of 40-60% and manageable side effects. Additionally, Carboplatin has been effective in increasing complete response rates in aggressive breast cancers, especially in patients with certain genetic mutations.12345

Is the combination of Carboplatin and Tocilizumab safe for humans?

Carboplatin is generally well-tolerated in humans, with mild side effects like nausea and low blood cell counts. Tocilizumab, used for other conditions, is also considered safe but can cause side effects like infections and liver enzyme changes. While specific safety data for the combination of Carboplatin and Tocilizumab in breast cancer is limited, both drugs have been used safely in humans for other conditions.13678

What makes the drug combination of Carboplatin and Tocilizumab unique for breast cancer treatment?

The combination of Carboplatin and Tocilizumab is unique because it pairs a chemotherapy drug (Carboplatin) with an immunotherapy drug (Tocilizumab), which is typically used to treat inflammation in conditions like rheumatoid arthritis. This novel approach aims to enhance the immune response against breast cancer, potentially offering a new treatment option for patients.123910

What is the purpose of this trial?

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.

Research Team

Kathy D. Miller, MD | IU Health

Kathy Miller, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults with metastatic triple negative or ER-low breast cancer who have completed prior therapy at least a year ago. They must be in good physical condition, have adequate organ function, and not be pregnant. Participants need to consent to biopsies and agree to use effective contraception. Those with treated brain metastases may join if stable.

Inclusion Criteria

I agree to a biopsy for this study.
Ability to provide written informed consent and HIPAA authorization
I have not had chemotherapy for cancer that has spread.
See 8 more

Exclusion Criteria

My cancer is HER2 positive based on specific test results.
I have not started hormone therapy in the last 2 weeks.
I have active or symptomatic brain or spinal cord problems.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either SOC chemotherapy monotherapy or SOC chemotherapy combined with tocilizumab

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • Carboplatin
  • Tocilizumab
Trial Overview The study compares carboplatin alone versus carboplatin combined with tocilizumab in patients with certain types of advanced breast cancer. It's randomized, meaning participants are assigned to one of the two treatment groups by chance.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Non-Black Combination treatmentExperimental Treatment2 Interventions
Group II: Black Combination treatmentExperimental Treatment2 Interventions
Group III: Black MonotherapyActive Control1 Intervention
Group IV: Non-Black MonotherapyActive Control1 Intervention

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kathy Miller

Lead Sponsor

Trials
8
Recruited
300+

Breast Cancer Research Foundation

Collaborator

Trials
79
Recruited
40,500+

Susan G Koman for the Cure Breast Cancer Foundation

Collaborator

Trials
1
Recruited
170+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

In a phase II study involving 22 patients with BRCA1/2-related metastatic breast cancer, the combination of pembrolizumab and carboplatin showed an overall response rate (ORR) of 43% and a disease control rate (DCR) of 76%, indicating some level of efficacy, particularly in luminal tumors.
Despite the promising results, the study did not meet its primary aim of achieving an ORR of 70%, leading to its termination; however, the safety profile was acceptable with only 22.7% of patients experiencing grade ≥3 adverse events.
A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA).Cortesi, L., Venturelli, M., Cortesi, G., et al.[2023]
In a study of 55 women with resectable and locally advanced breast cancer, neoadjuvant treatment with carboplatin and weekly paclitaxel, with or without trastuzumab, resulted in a high pathologic complete response (pCR) rate of 45%, particularly in patients with HER2-positive tumors (76% pCR rate).
The treatment was well tolerated, with no severe side effects like febrile neutropenia, and showed promising recurrence-free survival (RFS) rates of 88.7% at a median follow-up of 28 months, suggesting the regimen's effectiveness and safety in high-risk breast cancer patients.
Frequent pathologic complete responses in aggressive stages II to III breast cancers with every-4-week carboplatin and weekly paclitaxel with or without trastuzumab: a Brown University Oncology Group Study.Sikov, WM., Dizon, DS., Strenger, R., et al.[2022]
In a trial involving patients with advanced breast cancer who had prior chemotherapy, carboplatin showed no objective responses, indicating limited efficacy in this group.
In contrast, preliminary results from an ongoing trial with patients who had no prior chemotherapy exposure showed a 32% overall response rate, suggesting that carboplatin may be more effective in treatment-naive patients, with mild toxicity reported.
Phase II study of carboplatin in advanced breast cancer: preliminary results.Martin, M., Diaz-Rubio, E., Casado, A., et al.[2013]

References

A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA). [2023]
Frequent pathologic complete responses in aggressive stages II to III breast cancers with every-4-week carboplatin and weekly paclitaxel with or without trastuzumab: a Brown University Oncology Group Study. [2022]
Phase II study of carboplatin in advanced breast cancer: preliminary results. [2013]
Paclitaxel-carboplatin combination chemotherapy in advanced breast cancer: accumulating evidence for synergy, efficacy, and safety. [2018]
Assessing the role of platinum agents in aggressive breast cancers. [2022]
Atezolizumab plus carboplatin and nab-paclitaxel versus carboplatin and nab-paclitaxel as treatments for Chinese, treatment-naïve, stage IV, non-squamous, non-small-cell lung cancer patients: A retrospective analysis. [2022]
Carboplatin and nab-paclitaxel chemotherapy with or without atezolizumab as front-line management for treatment-naïve metastatic nonsquamous non-small cell lung cancer with PD-L1 staining: a retrospective study. [2023]
Probable cutaneous hypersensitivity to carboplatin single-agent chemotherapy in a dog. [2013]
A phase II study of pemetrexed and carboplatin in patients with locally advanced or metastatic breast cancer. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel and carboplatin as first-line chemotherapy for advanced breast cancer. [2015]
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