Platinum Chemotherapy for Triple-Negative Breast Cancer

Not currently recruiting at 1045 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ECOG-ACRIN Cancer Research Group

Disqualifiers: History of TNBC, Concurrent malignancies, others

Stay on Your Current Meds You can continue your current medications while participating

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 7

Duration: 12-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether the chemotherapy drugs cisplatin or carboplatin (both platinum-based) are more effective than capecitabine in treating triple-negative basal-like breast cancer that persists after initial chemotherapy and surgery. The trial will assess if these drugs can more effectively stop cancer cells from growing or spreading. Suitable participants are those who have undergone chemotherapy and surgery for stage II or III triple-negative breast cancer but still have residual cancer in the breast. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants access to potentially effective treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, adjuvant chemotherapy other than specified in the protocol is not allowed, but certain medications like LHRH agonists and bisphosphonates are permitted. It's best to discuss your current medications with the trial team.

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

Research shows that both carboplatin and cisplatin have undergone safety studies for treating triple-negative breast cancer. Studies indicate that carboplatin is generally well-tolerated, with manageable side effects like low blood counts, nausea, or fatigue. A review of various studies shows that cisplatin is also considered safe, with common side effects similar to those of carboplatin. Both treatments have been safely used in clinical settings for cancer.

These treatments have also been applied to other cancer types, further supporting their safety. Prospective trial participants can find reassurance in the thorough safety studies of these drugs. Always consult a doctor to understand how these treatments might affect you personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about platinum-based chemotherapy, using Carboplatin and Cisplatin, for triple-negative breast cancer because these drugs offer a unique approach to attacking cancer cells. Unlike standard treatments such as anthracyclines and taxanes, Carboplatin and Cisplatin work by binding to the DNA of cancer cells, causing damage that prevents them from multiplying. This mechanism can be particularly effective for triple-negative breast cancer, which lacks the hormone receptors that many other treatments target. Additionally, these drugs can be administered intravenously, allowing for precise dosing and potentially reducing side effects compared to oral treatments. The potential for more targeted action and the ability to tackle aggressive cancer cells makes this approach a promising alternative to existing therapies.

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

Research has shown that platinum-based chemotherapy, such as carboplatin, holds promise for treating triple-negative breast cancer. In this trial, some participants will receive carboplatin. Studies have found that it can help patients with early-stage triple-negative breast cancer live longer and reduce the chance of recurrence. After three years, 77.9% of patients using carboplatin experienced no cancer return, and 87.6% remained alive.

Other participants in this trial will receive cisplatin. Studies suggest that cisplatin has strong effects against tumors and can improve outcomes for patients with residual tumors after initial treatment. Cisplatin has maintained its effectiveness, potentially leading to better chances of staying cancer-free in triple-negative breast cancer. Both treatments show potential, but it remains unclear which one might be more effective for this specific condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Ingrid Mayer

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for adults with triple-negative breast cancer that remains after initial chemotherapy and surgery. Participants must have completed neoadjuvant taxane +/- anthracycline therapy, not received cisplatin, carboplatin, or capecitabine as part of this regimen, and meet certain health criteria like specific blood cell counts and liver function.

Inclusion Criteria

I can receive radiotherapy before or after the trial treatment as per standard guidelines.

I completed a specific chemotherapy regimen without cisplatin, carboplatin, or capecitabine.

I have not received any chemotherapy after surgery that is not listed in this study.

Exclusion Criteria

I had triple-negative breast cancer within the last 5 years and no other cancers.

I do not have any serious infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cisplatin or carboplatin intravenously every 3 weeks for 4 courses, or capecitabine orally twice daily for up to 6 courses

12-18 weeks

4-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cisplatin

Trial Overview

The study compares the effectiveness of platinum-based chemotherapy (cisplatin or carboplatin) versus capecitabine in patients with residual basal-like triple-negative breast cancer post-surgery. It aims to determine which treatment better stops tumor growth by killing cells or preventing their spread.

How Is the Trial Designed?

Group I: Arm B (cisplatin or carboplatin) Experimental Treatment 2 Interventions

Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (observation) (closed to accrual 05/16/2016) Active Control 1 Intervention

Patients undergo observation.

Group III: Arm C (capecitabine) Active Control 1 Intervention

Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a clinical trial involving 90 patients with triple negative breast cancer (TNBC), the optimal chemotherapy regimen combined carboplatin with standard dose-dense ACT, resulting in the lowest grade 3 or 4 toxicities and no delays or dose reductions for carboplatin.

The study identified reduced protein levels of androgen receptor and PD-L1 as potential indicators of treatment response, with Stage I patients showing a zero relapse rate, suggesting the effectiveness of the carboplatin-based regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective phase II clinical trial identifying the optimal regimen for carboplatin plus standard backbone of anthracycline and taxane-based chemotherapy in triple negative breast cancer. Hamm, C., Fifield, BA., Kay, A., et al.[2022]

In a study of 190 patients with stage I-III triple-negative breast cancer (TNBC), the neoadjuvant regimen of carboplatin and docetaxel (CbD) achieved a high pathologic complete response (pCR) rate of 55%, indicating effective tumor reduction before surgery.

The CbD regimen was well tolerated, with only 21% of patients experiencing grade 3 or 4 adverse events, suggesting it is a safe treatment option comparable to traditional chemotherapy combinations that include anthracyclines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Neoadjuvant Carboplatin plus Docetaxel in Triple-Negative Breast Cancer: Combined Analysis of Two Cohorts. Sharma, P., López-Tarruella, S., García-Saenz, JA., et al.[2022]

Carboplatin is a less toxic alternative to cisplatin, allowing for comparable antitumor doses with reduced side effects, particularly in terms of nephrotoxicity and severity of nausea and vomiting.

In phase I studies involving various adult and pediatric cancers, carboplatin showed objective responses while primarily causing reversible myelosuppression, with recommended dosing strategies established for further clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of NCI-sponsored phase I trials with carboplatin. Foster, BJ., Clagett-Carr, K., Leyland-Jones, B., et al.[2019]

Cisplatin and carboplatin are both effective platinum-based chemotherapy agents, but they differ significantly in their side effects; cisplatin can cause severe kidney damage and neurotoxicity, while carboplatin is safer for renal function and has less neurotoxicity.

Carboplatin's toxicity profile allows for dose adjustments based on renal function, making it a more manageable option for patients, whereas cisplatin requires hydration protocols to mitigate its harmful effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative adverse effect profiles of platinum drugs. McKeage, MJ.[2018]

In a Phase I trial involving 18 patients with advanced non-small cell lung cancer (NSCLC), the combination of carboplatin and cisplatin was found to have a manageable toxicity profile, with thrombocytopenia being the main dose-limiting effect and a maximum tolerated dose of 350 mg/m2 for carboplatin.

In a subsequent Phase II trial with 13 patients, using a safer carboplatin dose of 300 mg/m2, 38.5% of patients showed a partial response to the treatment, indicating that this combination chemotherapy may be effective for advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined carboplatin and cisplatin therapy in patients with advanced non-small cell lung cancer. Nakanishi, R., Kume, T., Mitsudomi, T., et al.[2019]

A phase I trial involving 33 patients tested the combination of cisplatin and carboplatin, revealing that while the combination is feasible, it can lead to unexpectedly severe thrombocytopenia (low platelet count) when using specific doses, particularly 280 mg/m2 carboplatin with 25 mg/m2 cisplatin.

Despite the risk of thrombocytopenia, the combination therapy showed promising responses in tumors known to be responsive to platinum-based treatments, suggesting that further investigation into this combination is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platinum analogue combination chemotherapy: cisplatin and carboplatin--a phase I trial with pharmacokinetic assessment of the effect of cisplatin administration on carboplatin excretion. Trump, DL., Grem, JL., Tutsch, KD., et al.[2017]

In a study of 42 patients with advanced seminoma, 71% achieved complete remission with carboplatinum treatment, indicating it is an effective option for this type of cancer.

Carboplatinum therapy showed mild toxicity with no neurotoxicity or nephrotoxicity, suggesting it may be a safer alternative to traditional cisplatin-based chemotherapy, especially for patients with lymph node metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-agent carboplatinum for advanced seminoma. A phase II study. Schmoll, HJ., Harstrick, A., Bokemeyer, C., et al.[2019]

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