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NCT Number: NCT04360330

SABER Study for Selected Early Stage Breast Cancer

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Cristiane Takita, MD, MBA

PRINCIPAL_INVESTIGATOR

Zuzel Rodriguez

CONTACT

[email protected]

305-243-0124

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Stereotactic Ablative Breast Radiotherapy

Radiation

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 fractions of 8 Gy)
  • Dose Level III: 45 Gy (5 fractions of 9 Gy)
  • Dose Level IV: 50 Gy (5 fractions of 10 Gy)

Other names: SABER

Primary outcomes

  1. Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER

    Time frame: Up to 13 Weeks

    The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Secondary outcomes

  1. Number of Participants Experiencing Treatment-Related Toxicity

    Time frame: Up to 13 weeks

    Number of participants experiencing treatment-related toxicity by type and grade including adverse event (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs). Toxicity will be evaluated using the NCI CTCAE version 5.0.

  2. Percentage of participants with Complete Pathological Response (pCR)

    Time frame: Up to 9 weeks

    pCR will be defined as a negative pathologic specimen for invasive carcinoma. The specimen used for evaluation will be the tissue samples obtained from standard of care partial mastectomy and axillary surgery as per discretion of treating physician.

  3. Cosmesis Evaluation

    Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years

    Participant cosmesis will be evaluated-by-physician at 1, 6,12 and 24 months post-SABER therapy and post-surgical follow-up, using the Harvard 4-point ordinal scale (excellent, good, fair, and poor).

  4. Participant-Reported Health-Related Quality of Life (HR-QoL)

    Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years

    The Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire will be used to assess participant-reported health-related quality of life (HR-QoL) at 1, 6 12, 24 months post-SABER therapy and post-surgical follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Zuzel Rodriguez

CONTACT

[email protected]

305-243-0124

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: SABER

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Apr 24, 2020
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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