Recruiting
Phase 2

Observational Study

Sponsor:

Baylor Breast Care Center

Code:

NCT05020860

Conditions

Breast Cancer

Breast Neoplasm

Breast Cancer Female

Breast Cancer Invasive

Breast Cancer Stage II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Carboplatin

Trastuzumab

Pertuzumab

Doxorubicin

Study Details

Brief summary:

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Conditions

Breast Cancer

Breast Neoplasm

Breast Cancer Female

Breast Cancer Invasive

Breast Cancer Stage II

Study ID

NCT05020860

Start date

Apr 18, 2023

Status verified date

Jan, 2025

Completion date

Nov, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
  • Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).

To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score < 6; 4) Ki-67 ≥ 30%.

  • Tumors must be at least 2 cm by clinical exam or ultrasound
  • Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
  • ECOG performance status of 0 or 1
  • Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
  • Adequate organ function, as determined by the following parameters:

  • Absolute Neutrophil Count (ANC) ≥ 1200/mm3
  • Platelets ≥ 100,000/mm3
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome
  • Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
  • Serum creatinine ≤ institutional ULN
  • The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.
  • Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of Stage IV disease
  • Inflammatory breast cancer
  • Participants who are pregnant or lactating
  • History of an excisional biopsy or lumpectomy performed prior to study entry
  • Prior treatment with anthracyclines for any malignancy.
  • Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
  • History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:

  • Angina pectoris requiring the use of anti-anginal medication
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with documented compromise in cardiac function
  • Symptomatic pericarditis
  • Documented cardiomyopathy
  • History of documented congestive heart failure (CHF)
  • Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.
  • Current HIV, hepatitis B, or hepatitis C infection
  • History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
  • Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.
  • Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.

Study Design

Enrollment

185 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Triple Negative Breast Cancer (for tumors > 5 cm)

Paclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total)

active comparator: Triple Negative Breast Cancer (for tumors < 5 cm)

Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

active comparator: HER2-Positive Breast Cancer

Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)

active comparator: Hormone Receptor Positive Breast Cancer

Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

Interventions

Paclitaxel

80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle

Carboplatin

Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle

Trastuzumab

Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle

Pertuzumab

Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle

Doxorubicin

60 mg/m2 IV administered on Day 1 of each 14-day cycle

Cyclophosphamide

600 mg/m2 IV administered on Day 1 of each 14-day cycle

Pembrolizumab

Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen.

400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.

Pertuzumab/Trastuzumab/Hyaluronidase-zzxf

Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.

Primary outcome measure

  • Change in Clinical Tumor Measurement vs. Pathologic Response [ Time Frame: Baseline and at surgery (after 20 weeks) ]

Central Contacts and Locations

Central contacts

Maria Rodriguez

(713) 798-8347bcc-clinicalresearch@bcm.edu

Locations

Harris Health System - Smith Clinic

Recruiting

Houston, Texas, United States, 77054

Contacts

Maria Rodriguez

713-798-8347bcc-clinicalresearch@bcm.edu

Principal Investigator:

Mothaffar Rimawi, MD

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Maria Rodriguez

713-798-8347bcc-clinicalresearch@bcm.edu

Principal Investigator:

Mothaffar Rimawi, MD

More Information

Sponsor

Baylor Breast Care Center

Last update posted

Feb 27, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Breast Care Center on 2025-02-27.