SABER Study for Selected Early Stage Breast Cancer

Официальное название

Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer

Обзор

The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.

Вмешательства

• Лучевая терапия Stereotactic Ablative Breast Radiotherapy
  Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 frac

Первичные конечные точки

• Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER [Срок оценки: Up to 13 Weeks]

Вторичные конечные точки (4)

• Number of Participants Experiencing Treatment-Related Toxicity [Срок оценки: Up to 13 weeks]
• Percentage of participants with Complete Pathological Response (pCR) [Срок оценки: Up to 9 weeks]
• Cosmesis Evaluation [Срок оценки: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years]
• Participant-Reported Health-Related Quality of Life (HR-QoL) [Срок оценки: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years]

Критерии участия

Критерии включения

• Female, ≥ 50 years of age.
• Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
• Histologically confirmed invasive breast cancer.
• Clinical stage T1N0M0.
• Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
• Unifocal breast cancer.
• Eastern Cooperative Oncology Group (ECOG) 0, 1.
• Ability to undergo MRI.
• Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).

Критерии исключения

• Patients without histologically confirmed invasive breast cancer.
• Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
• Patients with metastatic disease.
• ECOG 2, 3, 4.
• Patients that are unable to undergo MRI.
• Prior history of radiation to the chest.
• History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
• Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
• Patients unable to consent, who are pregnant or nursing, or are prisoners.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT04360330 · 20190283

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗