Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer

NCT04083963 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2019-0550
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Nonrandomized, open label, single arm, Simon's two stage MinMax design trial of neoadjuvant weekly carboplatin plus paclitaxel, followed by doxorubicin and cyclophosphamide in patients with operable Triple Negative Breast Cancer (TNBC)

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Defined as the absence of residual invasive carcinoma in the resected breast specimen and ipsilateral axillary lymph nodes following completion of neoadjuvant therapy (i.e., ypT0/Tis, ypN0 per the American joint Committee on Cancer staging system) in all subjects completing at least 1 cycle of study treatment (modified intent-to-treat population)

  30 months

Secondary Outcomes (10)

• Pathologic complete response rate in subjects completing protocol therapy.

  30 months

• Residual Cancer Burden

  30 months

• Event-free survival (EFS)

  30 months

• Invasive disease-free survival (iDFS)

  30 months

• Distant disease-free survival (DDFS)

  30 months

Study Arms (1)

Single arm

OTHER

Low dose weekly carboplatin in combination with standard neoadjuvant chemotherapy

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

Interventions

Carboplatin DRUG

Low dose weekly carboplatin (AUC 2) will be combined with weekly paclitaxel for 12 weeks.

Also known as: Paraplatin

Single arm

Paclitaxel DRUG

Paclitaxel will be given weekly along with carboplatin for 12 weeks.

Also known as: Taxol

Single arm

Doxorubicin DRUG

Dose dense doxorubicin will be administered in combination with cyclophosphamide for 4 cycles after weekly carboplatin/paclitaxel.

Also known as: Adriamycin

Single arm

Cyclophosphamide DRUG

Does dense cyclophosphamide will be in combination with doxorubicin for 4 cycles after weekly carboplatin/paclitaxel.

Also known as: Cytoxan

Single arm

Eligibility Criteria

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

You may qualify if:

• Female ≥ 18 years of age at time of consent.
• Histologically confirmed invasive breast carcinoma documented by core needle biopsy or incisional biopsy (excisional biopsy is not allowed). AJCC clinical stage T1c, N0-3 or cT1, N1-3 by physical exam or radiologic studies. Suspected involvement of regional lymph nodes based on physical exam or imaging studies must be confirmed cytologically/histologically.
• Surgical excision of the primary breast tumor (partial mastectomy or total mastectomy) and ipsilateral axillary lymph node sampling (sentinel lymph node biopsy or axillary dissection) are planned following neoadjuvant chemotherapy.
• Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
• Triple-negative tumors are defined as:
• ER- and PR-negative: less than or equal to 10% tumor staining by immunohistochemistry (IHC) according to local pathology assessment.
• HER2-negative disease, defined as defined by ASCO/CAP guidelines \[24\]. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 28 days prior to study registration.
• Life expectancy of 6 months or greater as determined by the treating physician.
• Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to registration.
• System Hematological Leukocytes
• ,500/mm3 Platelet count
• ,000/mm3 Absolute Neutrophil Count (ANC)
• ,500/mm3 Hemoglobin (Hgb)
• g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr \< 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST)
• × ULN Alanine aminotransferase (ALT)

You may not qualify if:

• Active infection requiring systemic therapy.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer.
• Previous treatment with carboplatin, paclitaxel, doxorubicin, or cyclophosphamide within the past 3 years.
• Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
• A history of seizure within 6 months prior to study entry.
• Pre-existing neuropathy from any cause in excess of Grade 1.
• Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.
• Major surgery within 14 days prior to registration or has not recovered from major side effects
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating Medical Oncologist.
• Known history of AIDS (HIV testing is not mandatory). HIV-positive individuals on active HARRT therapy with virologic suppression (defined as an HIV-1 RNA level below the lower limit of detection of the assay used) within 90 days of study enrollment and a CD4 cell count \>500 cells/mm3 on the most recent determination are eligible for the study.
• History of myelodysplastic syndrome or acute myeloid leukemia.
• Subjects with any of the following conditions:
• History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration.
• History of cerebrovascular accident (CVA) or transient ischemic attack within 6 months prior to registration.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; 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; 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

• Kent Hoskins, M.D.

  University of Illinois at Chicago

  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

Model Details: Carboplatin plus paclitaxel followed by doxorubicin and cyclophosphamide

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 10, 2019
• Study Start: August 9, 2019
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)