Chemotherapy for Triple-Negative Breast Cancer

Not currently recruiting at 4 trial locations

Overseen By Alyson Clayborn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Anthracyclines, Taxanes

Disqualifiers: Stage IV cancer, Prior cancer, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new algorithm analyzing the genetic makeup of tumors can help doctors select the best treatment for patients with triple-negative breast cancer (TNBC). It tests tumors for specific proteins and immune cell activity to determine if this information can enhance treatment effectiveness. Participants will receive chemotherapy (also known as cytotoxic therapy), and the study will compare standard treatments to those tailored to the tumor's genetic profile. Individuals diagnosed with TNBC who have not started treatment might be suitable for this trial. As an unphased trial, this study offers patients the chance to contribute to pioneering research that could personalize cancer treatment in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this algorithm is safe for predicting treatment responses in triple-negative breast cancer?

Research has shown that chemotherapy for triple-negative breast cancer (TNBC) is generally well-tolerated. One study found that administering chemotherapy before the main treatment, known as neoadjuvant chemotherapy, is now a common approach for early-stage II-III TNBC, indicating its safety for many patients. Another study demonstrated that chemotherapy alone can completely shrink small tumors, proving its effectiveness and safety.

When immunotherapy is added to chemotherapy, studies indicate that this combination is well-accepted in medical practice. A review noted that adding pembrolizumab, a type of immunotherapy, to chemotherapy is now a standard treatment for certain stages of TNBC, confirming its safety. Another study found that this combination significantly improved survival and response rates for advanced TNBC patients, suggesting it is both safe and beneficial.

In summary, both chemotherapy and its combination with immunotherapy have demonstrated good safety in previous research, indicating they are well-tolerated by many TNBC patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it represents a personalized approach to treating triple-negative breast cancer. Unlike standard treatments that apply a one-size-fits-all method, this trial uses molecular and IHC evaluations to tailor chemotherapy and potential immunotherapy to the specific tumor subtype of each patient. This strategy not only aims to enhance treatment effectiveness but also provides insights into whether a tumor is likely to respond to chemotherapy. By potentially matching treatment to a tumor's genetic profile, researchers hope to improve outcomes and reduce unnecessary exposure to ineffective treatments.

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

Research has shown that chemotherapy effectively treats triple-negative breast cancer (TNBC). Specifically, chemotherapy has been linked to better survival rates for breast cancer patients. People with early-stage TNBC who receive chemotherapy often experience longer survival and more time without disease recurrence. In this trial, some participants will receive standard anthracycline-based chemotherapy alone, while others will receive it combined with immunotherapy. Adding immunotherapy to chemotherapy has shown promise and is now a standard treatment for certain stages of TNBC, improving patient outcomes. While predictions based on tumor analysis remain under study, current treatments have a strong track record. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinton Yam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed Stage I-III triple-negative breast cancer who can undergo biopsy or surgery. They must have adequate blood counts, organ function, and be eligible to receive specific chemotherapy regimens. Those with stage IV disease, prior invasive cancer treatments within 5 years (except certain skin cancers), poor performance status, heart issues, severe neuropathy or conditions affecting tumor assessment by imaging are excluded.

Inclusion Criteria

Leukocytes > 3,000/mcL

Platelets > 100,000/mcL

Total bilirubin =< 1.5 x upper limit of normal (ULN)

Exclusion Criteria

My cancer is at stage IV.

I haven't had invasive cancer in the last 5 years, except for treated skin cancer.

I have previously received chemotherapy or immunotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo baseline molecular and IHC evaluation, receive anthracycline-based chemotherapy, and undergo ultrasounds at baseline, after 2 cycles, and after 4 cycles of treatment.

12-16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up for up to 5 years.

5 years

Extension

Participants with tumors predicted to be insensitive to chemotherapy may participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype.

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Immunotherapy

Trial Overview

The study tests a new algorithm predicting treatment response in triple-negative breast cancer using genomic signatures of tumors. It compares standard care with personalized trials based on protein testing and lymphocyte infiltration analysis to see if tailored treatments improve tumor response.

How Is the Trial Designed?

Group I: Arm C (predictive results given) Experimental Treatment 5 Interventions

Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy with immunotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype

Group II: Arm B (predictive results given) Experimental Treatment 4 Interventions

Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.

Group III: Arm A (predictive results given) Experimental Treatment 4 Interventions

Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, after 4 cycles of treatment, and after completion of treatment (before surgery). Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Capecitabine significantly improves disease-free survival (DFS) and overall survival (OS) in early-stage triple-negative breast cancer (TNBC) patients when added to standard adjuvant chemotherapy, based on a meta-analysis of 11 randomized controlled trials involving 5,175 patients.

While capecitabine enhances survival outcomes, it is associated with increased risks of adverse effects such as diarrhea, hand-foot syndrome, and leukopenia, indicating that while it is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Capecitabine for Triple-Negative Breast Cancer: A Meta-Analysis. Xun, X., Cao, Q., Hong, P., et al.[2022]

Triple-negative breast cancer, which makes up 15%-20% of all breast cancers, has a high risk of relapse and death, highlighting the need for effective treatment strategies.

DNA alkylating agents like cisplatin have shown effectiveness in treating triple-negative breast cancer, especially when combined with targeted therapies such as PARP inhibitors, particularly for patients with BRCA1 mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The triple-negative subtype: new ideas for the poorest prognosis breast cancer. Curigliano, G., Goldhirsch, A.[2022]

Triple-negative breast cancer is a diverse and aggressive type of cancer, and while molecular characterization isn't standard practice, it can help in understanding the disease better and predicting outcomes.

Recent advances in treatment options include neoadjuvant platinum-based chemotherapy and targeted therapies for patients with BRCA mutations, which may improve outcomes in various stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the systemic treatment of triple-negative breast cancer. Lebert, JM., Lester, R., Powell, E., et al.[2023]

Cisplatin and capecitabine combination therapy showed a response rate of 62.1% in 29 patients with metastatic triple negative breast cancer (TNBC) who had previously progressed after other treatments, indicating its efficacy as a subsequent treatment option.

The therapy was generally well-tolerated, with most side effects being mild to moderate, although some patients experienced significant toxicities such as neutropenia and leukocytopenia, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of cisplatin plus capecitabine for patients with metastatic triple negative breast cancer progressing after anthracycline and taxane treatment]. Li, Q., Xu, B., Li, Q., et al.[2018]

Triple-negative breast cancer (TNBC) is sensitive to traditional chemotherapy agents like taxanes and anthracyclins, and patients with BRCA1 mutations can benefit from platinum-based treatments, especially when combined with PARP inhibitors.

While targeted therapies such as antiangiogenic agents and tyrosine kinase inhibitors have shown some effectiveness, they have not significantly improved overall survival in TNBC, highlighting the need for personalized treatment strategies based on the specific molecular characteristics of the cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic treatment strategies for triple-negative breast cancer. Yadav, BS., Sharma, SC., Chanana, P., et al.[2021]

Immune checkpoint inhibitors (ICIs) targeting PD-1 and PD-L1 have shown promising efficacy in treating metastatic triple-negative breast cancer (TNBC), a type of cancer with historically poor outcomes.

While ICIs can effectively induce antitumor responses, they also lead to unique immune-related adverse events (IRAEs) that require specific management strategies, including the use of corticosteroids and multidisciplinary care to ensure early recognition and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy toxicity: identification and management. Gumusay, O., Callan, J., Rugo, HS.[2022]

In a meta-analysis of 14 studies involving 3518 early-stage triple negative breast cancer patients, the addition of platinum agents to chemotherapy significantly improved disease-free survival (DFS) but did not affect overall survival (OS).

While platinum-based treatment showed better DFS (HR 0.71), it was associated with increased toxicity, including higher rates of thrombocytopenia and neuropathy, indicating that its use should be carefully considered in unselected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platinum-based chemotherapy in early-stage triple negative breast cancer: A meta-analysis. Saleh, RR., Nadler, MB., Desnoyers, A., et al.[2021]

Triple-negative breast cancer (TNBC) accounts for 10-20% of breast cancers and is linked to poorer outcomes, with higher recurrence and mortality rates compared to other types, highlighting the need for effective treatment strategies.

Current treatment primarily involves chemotherapy, particularly regimens with anthracyclines and taxanes, but many patients exhibit resistance; studies suggest that platinum-based therapies may offer better responses, indicating a potential shift towards personalized treatment based on genomic profiling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the Treatment of Triple-negative Early Breast Cancer. Basso, SM., Santeufemia, DA., Fadda, GM., et al.[2022]

Triple negative breast cancer is highly aggressive, and while systemic chemotherapy has improved outcomes for early-stage patients, metastatic recurrences remain a significant concern.

Adding carboplatin to standard chemotherapy regimens enhances the likelihood of achieving a complete pathologic response, although it increases toxicity; additionally, adjuvant capecitabine has been shown to improve long-term outcomes for patients with residual disease after neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early stage triple negative breast cancer: Management and future directions. Chaudhary, LN.[2021]

The combination of the photosensitizer indocyanine green and the natural drug parthenolide in thermosensitive liposomes showed a significant tumor inhibition rate, approximately 2.08 times greater than that of the traditional chemotherapy drug paclitaxel in a mouse model of triple-negative breast cancer.

This approach demonstrated good initial safety, suggesting that using non-cytotoxic agents with photosensitizers could provide a safer alternative for patients who cannot tolerate conventional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green-Parthenolide Thermosensitive Liposome Combination Treatment for Triple-Negative Breast Cancer. Jin, X., Lu, X., Zhang, Z., et al.[2022]

In a study of 9,256 patients with stage I triple-negative breast cancer (TNBC), those who received adjuvant chemotherapy showed significantly improved breast cancer-specific survival (BCSS) and overall survival (OS) compared to those who did not, particularly in stage T1cN0M0 and stage IB disease.

However, patients with stage T1aN0M0 or T1bN0M0 TNBC did not benefit from chemotherapy, suggesting that current treatment guidelines may lead to overtreatment in these cases, as their prognosis is already favorable without chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a beneficial effect of adjuvant chemotherapy in patients with stage I triple-negative breast cancer: a population-based study using the SEER 18 database. Du, ZL., Wang, Y., Wang, DY., et al.[2021]

In a study of 151 patients with metastatic triple-negative breast cancer, combined chemotherapy using platinum with taxol or vinorelbine showed a significantly higher efficacy (42.1%) compared to other treatments (23.1%).

The effectiveness of first-line chemotherapy was found to be a key prognostic factor for overall survival, with median survival times of 29.6 months for partial remission, 24.7 months for stable disease, and 13.1 months for progressive disease, indicating that initial treatment response is crucial for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of chemotherapeutic efficacies in metastatic triple-negative breast cancer]. Wu, SK., Zhao, X., Meng, XY., et al.[2018]

Adjuvant capecitabine significantly improves disease-free survival in early breast cancer patients, with a hazard ratio of 0.79, based on a review of six studies involving 6941 patients.

The most notable benefits were seen in triple-negative breast cancer patients, suggesting that capecitabine is a valuable treatment option for this group, although overall survival improvements were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional adjuvant capecitabine in early breast cancer patients: a meta-analysis of randomized controlled trials. Zhou, W., Cao, Y., Gou, P., et al.[2022]

In a meta-analysis of four randomized controlled trials involving 590 patients, first-line platinum-based chemotherapy significantly improved objective response rates in metastatic triple-negative breast cancer, increasing from 43.1% to 62.7%.

Patients receiving platinum-based chemotherapy experienced longer progression-free survival compared to those on platinum-free regimens, with a hazard ratio of 0.55, although there was a higher risk of grade 3-4 thrombocytopenia associated with the platinum treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Platinum-Based Chemotherapy as First-Line Therapy for Metastatic Triple-Negative Breast Cancer: A Meta-Analysis of Randomized Controlled Trials. Lu, F., Hou, Y., Chen, Z., et al.[2021]

Neoadjuvant chemotherapy followed by breast-conserving surgery in 100 patients with triple-negative breast cancer resulted in a significantly higher treatment effectiveness (82% vs. 56%) and reduced operation time and blood loss compared to surgery followed by chemotherapy.

Patients receiving neoadjuvant treatment also experienced better immune function post-surgery and a lower rate of postoperative complications (6% vs. 30%), along with improved quality of life measures one year after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant Chemotherapy Combined with Breast-Conserving Surgery in the Treatment of Triple-Negative Breast Cancer. Zhang, X., Li, H., Wu, F., et al.[2022]

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