Chemotherapy +/- Erbitux for Breast Cancer

(CA225200 Trial)

Recruiting at 57 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

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Metastatic Breast Cancer.

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 the combination of chemotherapy drugs like Irinotecan and Carboplatin safe for humans?

The combination of Irinotecan (also known as CPT-11 or Camptosar) and Carboplatin (also known as Paraplatin) has been studied in patients with lung cancer. Common side effects include low blood cell counts, diarrhea, and nausea, but these effects are generally manageable. Serious side effects like febrile neutropenia (fever with low white blood cell count) and severe diarrhea have been reported, but they are less common. ^{1 2 3 4 5}

How does the drug combination of Carboplatin and Irinotecan differ from other breast cancer treatments?

The combination of Carboplatin and Irinotecan (CPT-11) for breast cancer is unique because Irinotecan is a topoisomerase I inhibitor, which is not commonly used in standard breast cancer treatments. This combination is being explored for its potential effectiveness in cases where other treatments, like anthracyclines and taxanes, have been used previously. ^{2 5 6 7 8}

What data supports the effectiveness of the drugs used in the Chemotherapy +/- Erbitux for Breast Cancer trial?

Irinotecan (CPT-11) has shown effectiveness in treating various cancers, including lung and colorectal cancers, when combined with other drugs like carboplatin. However, its activity in advanced breast cancer is minimal or not clinically meaningful. ^{1 6 7 8 9}

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. United States pubmed.ncbi.nlm.nih.gov

Irinotecan and carboplatin in metastatic or recurrent non-small-cell lung cancer. [2018]

2. England 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. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[Clinical activity spectrum of irinotecan]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

In vitro sensitivity of fresh ovarian carcinoma specimens to CPT-11 (irinotecan). [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A phase I study of capecitabine combined with CPT-11 in metastatic breast cancer pretreated with anthracyclines and taxanes. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of irinotecan (CPT-11), 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin, and cisplatin in combination with fixed dose of vindesine in advanced non-small cell lung cancer. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Phase II study of irinotecan and carboplatin for advanced non-small cell lung cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

[CPT-11 (irinotecan)--evidence from molecular and pharmacological studies and clinical applications]. [2018]