- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05464667
Preoperative Irradiation for Stage I Breast Cancer
Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Demko, RN, BSN
- Phone Number: 412-623-1400
- Email: albesl@upmc.edu
Study Contact Backup
- Name: Brieana Marino, MS
- Phone Number: 412-647-8258
- Email: rowlesbm@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- UPMC Magee Womens Hospital - Radiation Oncology
-
Principal Investigator:
- Parul Barry, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0"
- Patient biologically of the female sex
Must meet ALL the following criteria:
3.1. Age ≥ 50 years
3.2. Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging.
3.3. All invasive subtypes and DCIS
3.4. ER positive, HER2/neu negative
3.5. No LVSI
3.6. Clinically negative lymph nodes based on results of dedicated breast imaging
- The gross tumor should be >1cm from the chest wall and the skin surface
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration
- Patients of child-bearing age should have either a negative urine or serum pregnancy test within 14 days of study entry.
- Patients of child-bearing age should be non-pregnant and non-lactating. They should use a medically acceptable form of contraception during RT.
- Patients must have signed this study's informed consent prior to study entry.
Exclusion Criteria:
- Clinically staged breast cancer that does not meet all of the criteria delineated in Inclusion criteria 3.
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- Prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible) unless disease free for a minimum of 5 years prior to study entry.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Two or more documented breast cancers within the index breast or bilateral breast cancer.
- Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Paget's disease of the nipple.
- Male breast cancer.
- Evidence of distant metastases.
- Clinical regional lymph node involvement.
- Prior RT to the region of the breast that would result in overlap of RT fields.
- Intention to administer concurrent chemotherapy for current breast cancer.
Severe, active co-morbidity, defined as follows:
13.1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
13.2. Transmural myocardial infarction within the last 6 months
13.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
13.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
13.5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
13.6. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
- Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- Unable to delineate tumor on pre-RT MRI and CT simulation scan.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation Therapy (RT)
Preoperative Dose-escalated RT (5 Cohorts): The first 3 patients to consent to the study will be registered to Cohort 1; the second 3 patients to consent will be registered to Cohort 2; the next 3 patients to consent will be registered to Cohort 3. The remaining patients will be assigned 2 patients to each Cohort, starting with Cohort 4. From that point on, a statistical analysis will be done to calculate the dose for the next Cohort (5). |
Dose Escalation: 5 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 45, 50 Gy in 5 fractions (Part 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Up to18 months (cohort)
|
Maximum tolerated dose (MTD) of RT, which will be defined based on the occurrence of grade 2 or higher acute radiation dermatitis as defined per National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE) v5.0, occurring within approximately 1 month after radiation therapy (RT).
Dose escalation will begin with 30 GY and be escalated to 35, 40, 45, and 50 GY as tolerated.
|
Up to18 months (cohort)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Toxicities
Time Frame: Up to 1 month
|
Frequency of toxicities (Adverse Events and Serious Adverse Events) including subcutaneous breast tissue, chest wall, fatigue, pain and wound healing issue as defined per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0, occurring within approximately 1 month after radiation therapy (RT).
|
Up to 1 month
|
Late toxicities
Time Frame: From 6 months, up to 24 months
|
Frequency of toxicities (Adverse Events and Serious Adverse Events) including subcutaneous breast tissue, chest wall, fatigue, pain and wound healing issues as defined per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0 occurring at and after 6 months after radiation therapy (RT).
|
From 6 months, up to 24 months
|
Pathologic Response (PR)
Time Frame: Up to 3 years
|
Residual Cancer Burden (RCB) estimates residual disease in the tumor bed and lymph nodes post-neoadjuvant therapy.
RCB values, determined by the pathologist, are derived using the largest two dimensions of the Primary Tumor Bed Area (mm) (largest tumor bed if multicentric disease), histological assessment of Overall Cancer Cellularity (as carcinoma percentage of area) and Percentage of Cancer That Is in situ Disease, along with Number of Positive Lymph Nodes (metastatic) and Diameter of Largest Nodal Metastasis (mm).
RCB scoring classes, indicating progressively larger residual disease burden, are: RCB-0 (0 = pCR-no burden), RCB-1 (≥0-1.36-minimal
burden), RCB-2 (1.37-3.28-moderate
burden), and RCB-3 (>3.28-extensive burden).
|
Up to 3 years
|
Quality of Life - EORTC QLQ BR23
Time Frame: At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT
|
The European Organization for Research and Treatment Quality of Life Questionnaire for Breast Cancer (EORTC QLQ BR23) is a breast-specific module that comprises of 20 four-level questions in five multi-item domains questions to assess functioning characteristics: body image, sexual functioning, sexual enjoyment, future perspective, and, symptom characteristics: systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.
Raw scores for each characteristic (ranging from 0 - 4) are linearly transformed to a 0 to 100 overall/total scale.
Better level of functioning is represented by a higher functional score for each characteristic.
More severe symptoms are represented by high symptom scores or items for each symptom.
|
At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT
|
Breast Cancer Treatment Outcome Scale (BCTOS)
Time Frame: At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT
|
Breast Cancer Treatment Outcome Scale (BCTOS) is a 17-item, self-report instrument of perceived aesthetic (e.g., breast shape) and functional status (e.g., pain, mobility) after breast conserving surgical treatment (BCT) and radiotherapy.
The Aesthetic Status subscale is comprised of 12 items with total scores between 0-48; the Functional Status subscale is comprised of 5 items with total possible scores between 0-20.
Patients asked to rate each item of the questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference, 2 = slight difference, 3 = moderate difference, 4 = large difference).
The score for each subscale is the unweighted mean of the ratings over all items belonging to that subscale.
Total score of the BCTOS is thus 0-68.
A higher score reflects less symmetry between the treated and the untreated breast and is therefore considered a measure of poor status.
|
At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT
|
Loco-regional recurrence
Time Frame: Up to 5 years
|
Reappearance (present after RT) of disease in the location/region in which initial disease appeared, as determined by physical exam and dedicated breast or systemic imaging using mammogram, MRI, CT, or PET scan.
|
Up to 5 years
|
Disease free Survival (DFS)
Time Frame: Up to 5 years
|
Length of time after treatment that patient show no evidence of reappearance of breast cancer.
Reappearance (present after RT) of disease is determined by physical exam and dedicated breast or systemic imaging using mammogram, MRI, CT, or PET scan.
|
Up to 5 years
|
Overall survival (OS)
Time Frame: Up to 5 years
|
Length of time from first study treatment until death due to any cause.
|
Up to 5 years
|
Cosmesis (cosmetic outcome)
Time Frame: At baseline (prior to RT), up to 3 years after RT
|
Digital images (photographs) will be taken of the breasts pre and post treatment.
These digital images will later be evaluated for cosmetic results by a panel of physicians using diagnostic established Radiation Therapy Oncology Group (RTOG) criteria, with patients receiving a rating of between 1 and 4. RTOG criteria ratings: 1-4: 1 = Excellent (minimal change in size, shape, texture) 2 = Good (mild change in shape, size texture, presence of reddening or scaring) 3 = Fair (moderate changes in size, shape involving 1/4 or less of breast, greater presence of reddening and scaring), 4 = Poor (severe thickening, scarring, change in size and shape involving greater than 1/4 of breast).
|
At baseline (prior to RT), up to 3 years after RT
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parul Barry, MD, UPMC Hillman Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC 22-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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