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New treatment option for Breast Cancer
Official title Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
ClinicalTrials.gov ID: NCT07188246
What this study is testing
What is Pembrolizumab (KEYTRUDA®)?
Pembrolizumab (KEYTRUDA®) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for breast cancer.
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
- This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy.
- Phase 2: a mid-size study of how well it works
- 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
You may be able to join if
- Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic...
- Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast...
- Lesion palpable by treating physician.
- Plan to be treated with neoadjuvant chemotherapy.
- Able to tolerate core needle biopsies and pembrolizumab injection.
You likely can't join if
- Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart...
- Prior treatment for current breast cancer.
- Previous radiation therapy to the same breast.
- Inflammatory breast carcinoma.
- Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.
- Recurrent breast cancer.
See the full eligibility criteria
- Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes.
- Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers. a. Clinical staging based on AJCC 8th edition.
- Lesion palpable by treating physician.
- Plan to be treated with neoadjuvant chemotherapy.
- Able to tolerate core needle biopsies and pembrolizumab injection.
- 18 years of age or older.
- Able to provide informed consent.
- Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).
- Prior treatment for current breast cancer.
- Previous radiation therapy to the same breast.
- Inflammatory breast carcinoma.
- Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.
- Recurrent breast cancer.
- Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients).
- Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis).
- No prior stem cell transplantation.
- Any poorly controlled autoimmune conditions.
- Current use of corticosteroids or immunosuppressants.
- Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable.
- Inability to tolerate core needle biopsies or pembrolizumab injection.
- Pregnant or lactating.
- Under 18 years of age.
- Inability or unwillingness to provide informed consent.
- Inability or unwillingness to complete study assessments/interventions and follow-up assessments.
The study team makes the final eligibility decision.
Where it's taking place
- London, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, 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.