Chemotherapy +/- Erbitux for Breast Cancer

(CA225200 Trial)

Not currently recruiting at 58 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: US Oncology Research

Must not be taking: Tyrosine kinase inhibitors

Disqualifiers: Uncontrolled cardiac disease, CNS metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Erbitux to standard chemotherapy improves treatment response in individuals with metastatic breast cancer, which has spread beyond the breast. Participants will receive either the chemotherapy drugs irinotecan and carboplatin (also known as Paraplatin) alone or with Erbitux. Ideal candidates have stage IV breast cancer, have not previously received irinotecan or carboplatin, and have undergone Herceptin therapy if their cancer is HER2 positive. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any concurrent chemotherapy not indicated in the study or any investigational agents. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining the drugs irinotecan and carboplatin, with or without Erbitux (cetuximab), has been tested for safety in people with advanced breast cancer. Studies have found that irinotecan can shrink tumors in 20-25% of patients who have already received treatment for this type of cancer. Additionally, adding Erbitux to carboplatin generally results in a well-tolerated treatment, with most patients not experiencing severe side effects.

Reports indicate that patients usually handle these treatments well. However, like any chemotherapy, side effects can occur. It is important to discuss the possible side effects and benefits with a healthcare provider to understand the risks and make an informed decision about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore adding Erbitux to a chemotherapy regimen for breast cancer, potentially enhancing the treatment's effectiveness. While standard care often involves drugs like doxorubicin, paclitaxel, or trastuzumab, this study investigates if combining Erbitux with irinotecan and carboplatin can improve outcomes. Erbitux works by targeting the epidermal growth factor receptor (EGFR), which is different from most conventional breast cancer treatments that don't specifically focus on this pathway. This unique mechanism could provide a new avenue for tackling breast cancer, offering hope for improved response rates and patient outcomes.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

This trial will compare two treatment approaches for metastatic breast cancer. One group will receive irinotecan and carboplatin, while the other group will receive irinotecan, carboplatin, and Erbitux. Research has shown that adding Erbitux to irinotecan and carboplatin might enhance treatment effectiveness for metastatic breast cancer. Studies have demonstrated promising results with this combination, as some patients responded better when Erbitux was included. However, despite improved treatment response, there was no significant increase in progression-free survival or overall survival. This indicates that while Erbitux may help shrink tumors or slow disease progression, it might not extend patients' lives. ^{1 4 5 6 7}

Who Is on the Research Team?

Joyce A. O'Shaughnessy, MD

Principal Investigator

US Oncology Research

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV metastatic breast cancer who've had up to one prior chemo regimen and no past treatment with irinotecan, carboplatin, or cisplatin. They must have measurable disease per RECIST Criteria and provide tissue samples. HER2 status needs documentation, and those with HER2+ must have had Herceptin therapy.

Inclusion Criteria

My breast cancer is confirmed and tested for HER2 status.

I have had one chemotherapy treatment for my advanced cancer.

I have not been treated with irinotecan, carboplatin, or cisplatin.

Exclusion Criteria

I have been treated with irinotecan, carboplatin, or cisplatin before.

I have been treated with drugs targeting EGFR. I've had Herceptin if my cancer is HER2+.

I have early or nonmeasurable metastatic breast cancer, or a different condition than specified in the first criterion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive irinotecan and carboplatin therapy with or without Erbitux in 21-day cycles

2 years

Visits on Days 1 and 8 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Erbitux
• Irinotecan

Trial Overview The study aims to compare the effectiveness of two chemotherapy combinations in treating metastatic breast cancer: irinotecan + carboplatin + erbitux versus irinotecan + carboplatin alone. The main goal is to see how well tumors respond to these treatments.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)

Group II: Arm 1 Active Control 1 Intervention

irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)

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

Who Is Running the Clinical Trial?

US Oncology Research

Lead Sponsor

Trials

38

Recruited

17,400+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

CPT-11 (irinotecan) is an effective anticancer drug that inhibits DNA topoisomerase 1 and has shown activity against solid tumors, including those resistant to other treatments, based on results from three European phase I trials.

The optimal dosage schedule for CPT-11 was determined to be 350 mg/m2 administered as an intravenous infusion once every 3 weeks, as it provided the highest dose intensity with manageable toxicity, particularly with the use of high-dose loperamide for diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for the dosage and schedule of CPT-11 (irinotecan) selected for phase II studies, as determined by European phase I studies. Armand, JP., Extra, YM., Catimel, G., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4698217/

N0436 (Alliance): A phase II trial of irinotecan plus cetuximab ... As a result, the median survival of MBC from diagnosis is approximately 18 to 29 months (mo) and the 5-year survival rate of MBC is less than 25%. These data ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3413275/

TBCRC 001: Randomized Phase II Study of Cetuximab in ... The TNBC subset of a randomized study of cetuximab added to irinotecan plus carboplatin also found improved RR, but no improvement in PFS or OS was seen; as in ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT00248287/Prot_SAP_000.pdf

protocol 04-070 28, 29 We hypothesize that the addition of Erbitux to ICb will increase the overall response rate of the ICb combination and will prolong the ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)35213-5/fulltext

Targeting triple-negative breast cancer Preliminary results of a randomized phase II study of weekly irinotecan/carboplatin with or without cetuximab in patients with metastatic breast cancer.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419352135

reviews Targeting triple-negative breast cancer A randomised phase II trial demonstrated promising overall response rates [ORR] (17% versus 6% ) when carboplatin was added to single-agent cetuximab in ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00248287?draw=2&rank=1

NCT00248287 | PhII ICb With/Without Erbitux in MBC Pts The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with ...

7. withpower.com withpower.com/trial/chemotherapy---erbitux-for-breast-cancer-ad9ac

Chemotherapy +/- Erbitux for Breast Cancer The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with ...