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New treatment option for Breast Cancer
Official title Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
ClinicalTrials.gov ID: NCT04050228
What this study is testing
- What it's testing
- The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo.
- Which group you join is decided by chance.
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, women only
You may be able to join if
- Women ≥ 18 years of age
- Diagnosis of breast cancer with a primary tumour \>2cm in size
- With conditions meeting criteria for chemotherapy administration
- Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
- Creatinine ≤175 µmol/L
You likely can't join if
- Inflammatory breast cancer
- Contraindications to neoadjuvant treatment including pregnancy or lactation
- Past medical history of connective tissue disease
- Past history of dermatologic disease involving the breast
- Eastern Cooperative Group Status (ECOG) ≥3
- No peripheral neuropathy of a severity of grade ≥2
See the full eligibility criteria
- Women ≥ 18 years of age
- Diagnosis of breast cancer with a primary tumour \>2cm in size
- With conditions meeting criteria for chemotherapy administration
- Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
- Creatinine ≤175 µmol/L
- Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
- Cardiac function (left ventricular ejection fraction) ≥55%
- Eligible for neoadjuvant chemotherapy.
- Inflammatory breast cancer
- Contraindications to neoadjuvant treatment including pregnancy or lactation
- Past medical history of connective tissue disease
- Past history of dermatologic disease involving the breast
- Eastern Cooperative Group Status (ECOG) ≥3
- No peripheral neuropathy of a severity of grade ≥2
- Evidence of distant metastatic disease
- Known sensitivity to components present in ultrasound gel.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.