No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
138 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients must have pathologically confirmed breast cancer.
* Patients will have an assigned sex of female at birth.
* Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or fl…
Inclusion Criteria:
* Patients must have pathologically confirmed breast cancer.
* Patients will have an assigned sex of female at birth.
* Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or flap-based approach.
* Patients will have pathologic stage T1-3 N0-1 M0 disease with indication for comprehensive post-mastectomy radiotherapy to the ipsilateral chest wall and regional lymph node basins (axilla, SCV, IMN).
* Patient/LAR willing to sign and date consent form
* Age ≥ 18
* ECOG Performance Status of ≤ 2
Exclusion Criteria:
* Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
* Patients planned to receive a scar or chest wall, or other boost.
* Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., \>2.0 Gy per fraction).
* Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
* Patients who have an active rash in the cervical or thoracic region.
* Patients taking systemic steroids \>10 mg/day.
* Patients on active antimicrobial treatment at the time of study enrollment.
* Patients with a prior history of organ or bone marrow transplant.
* Patients who are pregnant or nursing
* Prior Treatment:
* Patients with prior history of radiotherapy to the neck, thorax or abdomen.
* Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2, alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).
* Comorbid conditions:
o Active infection requiring parenteral antibiotic(s)
* Concomitant Medications:
o Concurrent systemic therapy during the course are not allowed, including cytotoxic chemotherapy, immunotherapy, and targeted therapy. Last dose of these agents must be delivered at least 2 weeks prior to start of radiotherapy and not to be restarted until at least 2 weeks following completion of radiotherapy. Endocrine therapy, pembrolizumab, Herceptin, Perjeta, and Kadcyla are allowed. Concurrent oral steroid medications are not allowed.
* Allergies:
* History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
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