Chemotherapy for Triple Negative Breast Cancer

Overseen By Kent F. Hoskins

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Must not be taking: Hormonal agents

Disqualifiers: Active infection, Seizure, Neuropathy, 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)

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

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a chemotherapy treatment plan for individuals with Triple Negative Breast Cancer (TNBC). It tests a medication mix that includes carboplatin, paclitaxel, doxorubicin, and cyclophosphamide to assess their combined effectiveness in treating TNBC before surgery. The trial seeks women with confirmed TNBC who plan to undergo surgery after chemotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any ovarian hormonal replacement therapy or hormonal agents like raloxifene or tamoxifen before starting the study treatment. Other medications are not specifically mentioned, so 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 shows that the treatments used in this trial—Carboplatin, Cyclophosphamide, Doxorubicin, and Paclitaxel—are generally well-tolerated by people with triple-negative breast cancer (TNBC), though some risks exist.

Carboplatin has helped TNBC patients live longer, although it might not always prevent cancer from returning or progressing. Cyclophosphamide, when included in certain chemotherapy plans, has shown high success rates in TNBC patients.

Doxorubicin improves response rates and survival, and studies have shown it to be safe for the heart over the long term in high-risk breast cancer patients. Lastly, Paclitaxel, often used with other drugs, is effective and generally well-tolerated. It is considered a good option for treating advanced TNBC.

While these treatments are promising, they may have side effects. It's important to discuss with the trial team what to expect and how side effects might be managed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Triple Negative Breast Cancer?

Researchers are excited about this chemotherapy treatment for triple-negative breast cancer because it combines low-dose weekly carboplatin with standard neoadjuvant chemotherapy. This approach is unique because it aims to enhance the effectiveness of traditional chemotherapy by using carboplatin more frequently at a lower dose, which may improve the body's ability to fight cancer cells. Unlike standard treatments that often involve higher doses over longer intervals, this regimen could potentially reduce side effects while maintaining or even boosting anti-cancer activity. This innovative strategy could offer a more tolerable and effective option for patients with this aggressive type of breast cancer.

What evidence suggests that this trial's treatments could be effective for Triple Negative Breast Cancer?

Research has shown that adding carboplatin to treatment can increase success rates and improve survival in early triple-negative breast cancer (TNBC). In this trial, participants will receive low-dose weekly carboplatin combined with standard neoadjuvant chemotherapy. Studies indicate that patients receiving carboplatin have a better chance of complete recovery and a lower risk of cancer recurrence. Doxorubicin also helps TNBC patients live longer. When combined with cyclophosphamide, doxorubicin can lead to better outcomes for those with triple-negative breast cancer. Paclitaxel, often used with other treatments, is effective and generally well-tolerated, making it a strong option for TNBC. Together, these treatments have shown promising results in fighting TNBC. ^{1 6 7 8 9}

Who Is on the Research Team?

Kent F. Hoskins

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for women over 18 with Triple Negative Breast Cancer (TNBC) that hasn't been treated before. They must not be pregnant or breastfeeding and willing to use two birth control methods. Participants should have a life expectancy of at least 6 months, an ECOG performance status of 0-2, and adequate organ function. The cancer must be operable, and they can't have had certain treatments or conditions that would affect the trial.

Inclusion Criteria

My breast cancer is triple-negative.

I am willing to use two effective birth control methods.

Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 14 days of study registration

Exclusion Criteria

I have mild or no nerve damage.

I haven't had major surgery in the last 2 weeks or still have major side effects from it.

I don't have any other cancers that could affect this treatment's safety or results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Segment 1

Participants receive weekly carboplatin and paclitaxel for up to 12 weeks, with possible dose modifications extending to 16 weeks

12-16 weeks

12 visits (in-person)

Chemotherapy Segment 2

Participants receive doxorubicin and cyclophosphamide every 14 days for 4 cycles

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cyclophosphamide
• Doxorubicin
• Paclitaxel

Trial Overview The study tests weekly Carboplatin plus Paclitaxel followed by Doxorubicin and Cyclophosphamide in patients with TNBC before surgery. It's a Phase 2 nonrandomized trial where all participants receive the same treatment sequence to see how effective it is in treating their breast cancer.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 4 Interventions

Low dose weekly carboplatin in combination with standard neoadjuvant chemotherapy

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?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

In a study using patient-derived xenografts from nine chemotherapy-naïve triple-negative breast cancer (TNBC) samples, docetaxel and carboplatin were found to be effective as single agents, while doxorubicin showed low activity.

The combination of docetaxel and carboplatin was more effective than either drug alone, particularly in models without hereditary mutations, highlighting the potential for optimized treatment strategies in TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of docetaxel, carboplatin, and doxorubicin in patient-derived triple-negative breast cancer xenografts. Martin, M., Ramos-Medina, R., Bernat, R., et al.[2021]

Paclitaxel, a novel antineoplastic drug, has shown significant effectiveness in treating advanced cancers such as ovarian, breast, non-small cell lung cancer, and head and neck cancer, with a potential to become a first-line treatment when combined with platinum for advanced ovarian cancer.

While initial hypersensitivity reactions posed challenges, current premedication strategies have reduced these side effects to less than 3%, although neutropenia remains a major dose-limiting adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol): a review of its antitumor activity in clinical studies Minireview. Hájek, R., Vorlicek, J., Slavik, M.[2015]

Paclitaxel is an effective treatment for treatment-refractory ovarian cancer, working by stabilizing microtubules to induce cytotoxicity, despite facing challenges like severe hypersensitivity reactions and formulation issues.

The drug is associated with significant side effects, including myelosuppression, mucositis, and neurotoxicity, which are dose-dependent, highlighting the need for careful management in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (taxol). Kohler, DR., Goldspiel, BR.[2019]

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]

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]

Paclitaxel (Taxol) is an effective chemotherapy agent for treating ovarian cancer and metastatic breast cancer, particularly in patients who have not responded to platinum-based treatments.

Nurses must be aware of the potential side effects of Paclitaxel, such as hypersensitivity reactions and peripheral neuropathy, and follow specific administration guidelines to avoid complications related to its interaction with PVC intravenous-giving sets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol)--a guide to administration. Preston, NJ.[2019]

The combination of doxorubicin, carboplatin, and weekly paclitaxel in treating advanced epithelial ovarian cancer (EOC) shows activity, with 4 out of 12 patients achieving partial remission and 3 having stable disease.

The main toxicity observed was myelosuppression, particularly grade 4 neutropenia, but the weekly administration of paclitaxel allowed for maintaining an effective dose intensity (approximately 65 mg/m²/week) while managing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of carboplatin, doxorubicin and weekly paclitaxel in patients with advanced ovarian carcinoma. Hess, V., Verrill, MW., Bomphray, CC., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12057025/

The impact of carboplatin on pathologic complete response ... It is known that adding carboplatin to NACT increases the complete response rate and positively affects DFS and OS in TNBC patients [7, 8]. The ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624000432

Platinum chemotherapy for early triple-negative breast ... Carboplatin reduces cancer recurrence in early triple negative breast cancer. Carboplatin chemotherapy improves survival in early triple negative breast cancer ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e12619

Efficacy and biomarker analysis of carboplatin plus taxanes ... The 3-year RFS and overall survival (OS) were 77.9%, 87.6%, respectively. Patients who achieved pCR had a significant better RFS (95.5%) and OS ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2769305

Effect of Adjuvant Paclitaxel and Carboplatin on Survival in ... Results of this study suggest that a paclitaxel-plus-carboplatin regimen may be an alternative adjuvant chemotherapy choice for patients with operable triple- ...

5. nature.com nature.com/articles/s41392-025-02137-7

Neoadjuvant apatinib addition to sintilimab and carboplatin ... Imaging evaluation showed 21 complete responses (61.8%) and 13 partial responses (38.2%). The most common grade 3-4 adverse events were ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0923753422000187

Long-term efficacy and safety of addition of carboplatin with ... At 4.5 years, adding carboplatin to neoadjuvant paclitaxel followed by AC improved event-free survival in stage II-III TNBC. •. Adding veliparib to carboplatin- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02531932

NCT02531932 | Comparison of Single-Agent Carboplatin ... The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-01023

A Phase III Randomized Controlled Trial Carboplatin did not significantly increase EFS but significantly increased the OS in patients with TNBC, with benefits confined to premenopausal ...

9. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(22)00286-5/abstract

Efficacy and Safety of First-line Carboplatin-paclitaxel and ... Of 88 consecutive advanced TNBC patients receiving first-line carboplatin-based doublets, 56 (63.6%) received CP and 32 (36.4%) CG. After ...