NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients

NCT06845319 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 104060
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm Phase II study to assess the efficacy of a 12-18 week neoadjuvant carboplatin, paclitaxel, and pembrolizumab (CPP) regimen in a response-adaptive manner for triple-negative breast cancer (TNBC) patients who are ineligible for anthracycline-based therapy due to underlying cardiac conditions.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pCR Rate in TNBC patients

  To determine the pCR rate in TNBC patients treated with the 12-18 weeks CPP regimen

  18 weeks

Secondary Outcomes (6)

• Radiological Response

  12 weeks

• Minimal Residual Disease Rate

  18 Weeks

• Event Free Survival

  3 years

• Overall Survival

  5 years

• Quality of life of patients with cardiac conditions undergoing the CPP regimen.

  5 years

Study Arms (1)

TNBC + non inflammatory Stage 2 3A/B

EXPERIMENTAL

Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab

Interventions

Paclitaxel DRUG

80mg/m2 weekly

TNBC + non inflammatory Stage 2 3A/B

Pembrolizumab DRUG

200 mg every 3 weeks for 4 cycles

TNBC + non inflammatory Stage 2 3A/B

Carboplatin DRUG

Carboplatin target AUC 5 every 3 weeks for 12-18 weeks OR target AUC 1.5 every week for 12-18 weeks (per investigator's choice).

TNBC + non inflammatory Stage 2 3A/B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Histologically confirmed triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA/B disease as defined by the AJCC 8th Edition Breast Cancer Stating System.
• a) The invasive tumor must be hormone receptor-negative or low, defined as estrogen receptor (ER) and/or progesterone receptor (PR) staining present in ≤10% of invasive cancer cells by immunohistochemistry (IHC).
• b) HER2-negative disease, defined in accordance with current ASCO-CAP HER2 guidelines.
• Measurable or evaluable tumor in the breast larger than 1 cm, with or without axillary involvement.
• Patients with multifocal or multicentric disease are eligible, provided the dominant tumor focus is ER and/or PR ≤10% and HER2 negative.
• Female or male, age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Medically fit to undergo curative-intent breast surgery per institutional standard of care.
• No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed).
• Ability to be followed by a cardiologist and/or primary care physician for optimization of cardiac comorbidities, as needed.
• Adequate organ function at the time of screening, defined as:
• a) Hematologic
• Absolute neutrophil count ≥1,500/µL.
• Platelet count ≥100,000/µL.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Subject is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
• Current diagnosis of metastatic or inflammatory breast cancer.
• Patients deemed unfit to undergo curative surgery according to the standard of care.
• Patients who have concomitant and/or previous malignancies within the last 5 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ (DCIS), carcinoma in situ of the cervix) that have undergone potential curative therapy are NOT excluded.
• History of hypersensitivity to compounds that are similar to carboplatin and paclitaxel.
• Has received major surgery and has not recovered adequately from the toxicity and/or complications before starting study treatment.
• Subject has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza or COVID vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy (7-day clearance period for immunosuppressant therapy prior to starting study treatment, if applicable).
• Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
• Has a history of solid organ transplant.
• Has a history of non-infectious pneumonitis that required high-dose steroids and/or has current pneumonitis.
• Has an active bacterial infection requiring systemic therapy.
• Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Abi Siva, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abirami Sivapiragasam

CONTACT

843-792-9300; sivapira@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 25, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)