Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer

NCT04243616 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00037175
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.

Conditions

Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of subjects with pathological complete response.

  This is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

  27 weeks from start of treatment

Study Arms (1)

Drug Treatment

EXPERIMENTAL

Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide

Drug: Cemiplimab; Drug: Paclitaxel; Drug: Carboplatin (not mandatory); Drug: Doxorubicin; Drug: Cyclophosphamide

Interventions

Cemiplimab DRUG

350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)

Also known as: Libtayo

Drug Treatment

Paclitaxel DRUG

80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)

Also known as: Taxol, Abraxane

Drug Treatment

Carboplatin (not mandatory) DRUG

Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)

Also known as: Paraplatin

Drug Treatment

Doxorubicin DRUG

60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)

Also known as: Lipodox, Lipodox 50, Doxil

Drug Treatment

Cyclophosphamide DRUG

600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)

Also known as: cytophosphane, Cytoxan, Neosar

Drug Treatment

Eligibility Criteria

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

You may qualify if:

• Pathologically proven diagnosis of invasive breast cancer, cT1-T3, cN0-N3, cM0, HR+ (ER+ and/or PR+) HER2 negative or HR- (ER- and PR-) HER2 negative/triple negative breast cancer.
• Tumors with positive PD-L1 and/or PD-L1 protein expression. Positivity is defined as PD-L1 and/or PD-L2 expression of ≥ 1% of immune cells within the stroma or in cancer cells.
• Estrogen and/or progesterone receptor positive tumor defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines.
• HER2/neu must be negative by immunohistochemistry (IHC) defined as IHC 0 or 1+ or fluorescence in situ hybridization (FISH) or other ISH methods with a ratio of \< 2 according to current ASCO (American Society of Clinical Oncology)/CAP guidelines.
• Candidate for neoadjuvant chemotherapy due to their clinical stage or subtype of breast cancer as decided by the treating physician.
• Breast imaging with mammogram and/or ultrasound and/or MRI is per standard of care for diagnosis, but at least one modality of imaging must be completed within 30 days of registration.
• Systemic imaging with CT scan, bone scan, positron emission tomography (PET) scan or MRI if clinically indicated per treating physician's discretion.
• Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (per institutional normal) determined by echocardiogram or nuclear medicine scan within 30 days of registration.
• The patient must be female.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• The patient must provide study-specific informed consent prior to study entry.
• Patients with a prior history of contralateral breast cancer will be considered eligible, if they have completed all treatment (including endocrine therapy) more than two years prior to registration.
• Patients must not have had a prior treatment for this breast cancer or for any malignancy diagnosed or treated within the past two years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer, as described above.
• Patients with bilateral breast cancer are also eligible provided HER2 negativity is documented on both right and left breast cancer and patient is deemed to be a candidate for neoadjuvant chemotherapy by treating physician.

You may not qualify if:

• Patients with clinical or pathologically proven metastatic disease.
• HER2 positive disease as determined by either ISH or 3+ on IHC.
• Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
• Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ) without any concurrent invasive breast cancer
• Men with breast cancer. Male breast cancer is a rare event.
• Medical, psychiatric or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent.
• Pregnant or lactating women are ineligible.
• Treatment with any investigational drug within 30 days of registration. Prior treatment with any immunotherapy or chemotherapy for this breast cancer.
• Current grade ≥ 2 peripheral neuropathy (according to NCI CTCAE v. 5.0).
• Cardiopulmonary dysfunction defined as: Inadequately controlled angina, heart failure or serious cardiac arrhythmia not controlled by adequate medication.
• Active Hepatitis B defined as positive Hep B surface antigen (HBsAg) or Hepatitis C. Patients with previous hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \[anti-HBc\] antibody test) are eligible. If HBV DNA testing is positive, the patient is not eligible for study participation. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
• Positive test for HIV.
• History of symptomatic CHF⎯Grade ≥ 3 per NCI CTCAE v5.0 or New York Heart Association (NYHA) Class ≥ II.
• History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

cemiplimab; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; liposomal doxorubicin; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; 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

• Lubna Chaudhary, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: March 5, 2020
• Primary Completion: August 11, 2025
• Study Completion (Estimated): August 12, 2030
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)