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New treatment option for Breast Cancer
Official title Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
ClinicalTrials.gov ID: NCT05020860
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Taxol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- ECOG performance status of 0 or 1
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.