Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer

NCT03121352 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE6115
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab. Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.

Conditions

Metastatic Triple Negative Breast Cancer

Keywords

Carboplatin; Nab-Paclitaxel; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) in Patients Treated With CNP

  The number of people with tumor responses according to RECIST (V1.1). These responses include Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study

  Up to 24 months

Secondary Outcomes (3)

• Progression-free Survival (PFS) in Patients Treated With CNP

  Up to 24 months

• Disease Control Rate (DCR) in Patients Treated With CNP

  Up to 24 months

• Duration of Response in Patients Treated With CNP

  Up to 24 months

Study Arms (1)

Carboplatin + Nab-paclitaxel + Pembrolizumab

EXPERIMENTAL

Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab

Drug: Carboplatin; Drug: Nab-paclitaxel; Drug: Pembrolizumab

Interventions

Carboplatin DRUG

AUC 4.5 IV day 1 of 21-day cycle

Carboplatin + Nab-paclitaxel + Pembrolizumab

Nab-paclitaxel DRUG

75mg/m2 IV days 1, 8 and 15 of 21-day cycle

Also known as: Abraxane

Carboplatin + Nab-paclitaxel + Pembrolizumab

Pembrolizumab DRUG

200 mg IV every 21 days

Also known as: MK-3475

Carboplatin + Nab-paclitaxel + Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
• Subjects must have received no more than 2 prior therapies for this disease
• ECOG Performance Status 0-1
• Subjects must have normal organ and marrow function as defined below:
• Hemoglobin ≥ 10.0 g/dl
• Absolute neutrophil count ≥ 1,000/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin within normal institutional limits
• AST (SGOT) ≤ 2.5 X institutional upper limit of normal
• ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
• Serum creatinine ≤ 1.5 normal institutional limits
• Life expectancy of 12 weeks or more
• Subjects must have the ability to understand and the willingness to sign a written informed consent document
• Subjects must have measurable disease per RECIST v1.1
• Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes. A second post-treatment biopsy will be offered but will not be mandated

You may not qualify if:

• Prior treatment toxicities have not resolved to ≤ Grade 1 according to NCI CTCAE Version 4.0 (except for alopecia and neuropathy)
• Subjects receiving any other investigational agents
• Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women are excluded from this study
• Patients with conditions requiring immunosuppressive medications or chronic infections (including HIV infection, hepatitis B and C)
• Patients with chronic autoimmune disease
• Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
• Patients with evidence of active, non-infectious pneumonia
• Patients active infection requiring intravenous systemic therapy
• Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
• Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
• Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
• Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; 130-nm albumin-bound paclitaxel; Albumin-Bound 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; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Joseph Baar
• Organization: University Hospitals

joseph.baar@uhhospitals.org

216-844-8683

Study Officials

• Joseph Baar, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 of Medicine

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 20, 2017
• Study Start: May 19, 2017
• Primary Completion: February 20, 2022
• Study Completion: May 23, 2022
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2023-10

Locations

US (2)