An interventional study of Radiation Therapy (RT) in Breast Cancer, sponsored by Parul Barry. Active, not recruiting at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Parul Barry · Not applicable, Interventional, and Treatment
The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.
This trial is a dose escalation study where we will evaluate preoperative dose-escalated RT in four cohorts and determine the maximum tolerated dose (MTD)In the first cohort, patients will be assigned to receive the standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV). In the subsequent cohorts patients will receive 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy, 40 Gy, and 50 Gy respectively. An interim analysis will be performed after 40 Gy to assess toxicity.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Parul Barry is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Preoperative Dose-escalated RT (4 Cohorts): Cohort 1: standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV) Cohort 2: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy Cohort 3: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 40 Gy Cohort 4: 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 50 Gy
Radiation: Radiation Therapy (RT)
Dose Escalation: 4 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 50 Gy in 5 fractions (Par 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2)
Maximum tolerated dose (MTD)
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, and 50 GY as tolerated.
Time frame: Up to18 months (cohort)
Acute Toxicities
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).
Time frame: Up to 1 month
Late toxicities
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).
Time frame: From 6 months, up to 24 months
Pathologic Complete Response (pCR)
Absence of residual invasive disease after treatment. 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).
Time frame: Up to 3 years
Quality of Life - EORTC QLQ BR23
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.
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)
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.
Time frame: At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT
Loco-regional recurrence
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.
Time frame: Up to 5 years
Disease free Survival (DFS)
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.
Time frame: Up to 5 years
Overall survival (OS)
Length of time from first study treatment until death due to any cause.
Time frame: Up to 5 years
Cosmesis (cosmetic outcome)
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).
Time frame: At baseline (prior to RT), up to 3 years after RT
Plan to share: No
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