Breast Cancer study: Radiation vs Pembrolizumab
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®)?
An investigational injectable medicine being studied for high‑risk primary breast cancer. It is designed to block the PD‑1 protein on immune cells, potentially enhancing the immune response against tumor cells.
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 study wants to see if adding radiation and the drug pembrolizumab before standard chemotherapy improves the cancer’s response.
- Who it's for
- Women with stage II or III invasive triple‑negative breast cancer.
- What's involved
- Participants will receive a focused radiation treatment (SBRT) and two injections of pembrolizumab, then start regular chemotherapy. They will have scheduled visits for treatment, monitoring, and safety checks.
- Time commitment
- The program lasts about 6–8 months, with multiple clinic visits for radiation, drug injections, chemotherapy cycles, and follow‑up assessments.
- 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).
- 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 is enrolling
- 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, but 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?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.