Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

NCT06318897 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0645NCI-2024-02384
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Conditions

Stage 1 cT1b-T1cN0M0; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Pathologic Complete Response

EXPERIMENTAL

If a participant's tissue shows a pathological complete response to treatment, participants will receive up to 13 cycles of pembrolizumab alone. Pathological complete response means that the study team cannot find any evidence of cancer in the breast or lymph node tissue sample that was removed during the participants surgery, after the participant completes the 4 cycles of carboplatin, pembrolizumab and paclitaxel.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab

Non-Pathologic Complete Response

EXPERIMENTAL

If a participant's tissue does not show a pathological complete response, the participant will receive 4 cycles of pembrolizumab plus 2 other drugs (doxorubicin and cyclophosphamide), followed by 9 cycles of pembrolizumab alone.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab; Drug: Doxorubicin; Drug: Cyclophosphamide

Interventions

Carboplatin DRUG

Given by IV

Also known as: Paraplatin®

Non-Pathologic Complete Response; Pathologic Complete Response

Paclitaxel DRUG

Given by IV

Also known as: PACLITAXEL PROTEIN BOUND

Non-Pathologic Complete Response; Pathologic Complete Response

Pembrolizumab DRUG

Given by IV

Also known as: KEYTRUDA®

Non-Pathologic Complete Response; Pathologic Complete Response

Doxorubicin DRUG

Given by IV

Also known as: Doxorubicin Hydrochloride, Adriamycin PFS®, Adriamycin RDF™, Adriamycin®, Rubex®

Non-Pathologic Complete Response

Cyclophosphamide DRUG

Given by IV

Also known as: Cytoxan®, Neosar®

Non-Pathologic Complete Response

Eligibility Criteria

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

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER\<10%, PR\<10%, and HER2 negative (per 2018 ASCO CAP guidelines). All pathology will be confirmed at the MD Anderson Houston Campus. Participants with tumors designated as HER2 equivocal (per ASCO CAP guidelines) are eligible if in view of treating physician patient is not considered a candidate for HER2-targeted therapy. Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-9% by immunohistochemistry, are eligible if the treating physician considers the participants not eligible for adjuvant endocrine therapy.
• AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0. All participants with clinically suspicious nodes must undergo core or fine needle biopsy per standard clinical practice to pathologically assess at least 1 suspicious index node. Participants with suspicious nodes that are biopsy negative will be eligible.
• Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage 1 T1b-T1cN0M0 TNBC will be enrolled in this study.
• Male participants: A male participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
• Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
• The participant provides written informed consent for the trial.
• Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (appendix 3). Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
• Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study intervention.
• Non-English speaking participant can enroll in the study as long as they speak a language for which interpretation can be provided by a licensed interpreter either in person or virtually.
• Criteria for known HIV positive participants.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Stage 2, 3 or 4 Triple negative breast cancer
• Hormone Receptor positive and/or Human Epidermal Growth factor 2 (HER 2) positive breast cancer
• A WOCBP who has a positive urine pregnancy test within 72 hours prior to dose of study drug (see Appendix 2). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy.
• Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
• Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• 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 within 7 days prior to the first dose of study drug.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity (≥Grade 3) to any of the components or any of its excipients used in the study treatments.
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
• Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; Taxes; pembrolizumab; Doxorubicin; Cyclophosphamide

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; Economics; Health Care Economics and Organizations; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Oluchi Oke, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluchi Oke, MD

CONTACT

(832) 729-8362; oukaegbu@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)