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Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients

Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients - SAVI study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000021237
Enrollment
82
Registered
2016-05-01
Start date
2016-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Primary registration 1) Tumor =<3 cm 2) cN0M0 3) Tumor is both unifocal and unicentric 4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma 5) No prior history of breast cancer/ no bilateral breast cancer 6) No prior radiotherapy or chemotherapy for this breast cancer 7) Female and >40 years old 8) ECOG performance status 0-1 9) Informed consent was given Secondary registration 1) Primary registration had been done 2) Breast conserving surgery was performed 3) Pathologically tumor <3 cm 4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma after surgery 5) No extensive intraductal component 6) No lympho-vascular invasion 7) Surgical margin was not positive 8) pN0 9) Chemotherapy will be performed over 2 weeks later

Exclusion criteria

Exclusion criteria: Primary registration 1) Prior history of radiotherapy for chest 2) During pregnancy or lactating 3) Collagen disease 4) Psychiatric comorbidities 5) Prior invasive malignancy unless disease free for a minimum of 5 years 6) Uncontrolled diabetes mellitus 7) Attending physician believes the patient is not suitable for this study Secondary registration 1) No conserving surgery 2) Paget disease 3) Unsuitable state for brachytherapy 4) Cosmetic evaluation is fair or poor before brachytherapy 5) Duration between surgery and brachytherapy was over 8 weeks

Design outcomes

Primary

MeasureTime frame
Local control rate

Secondary

MeasureTime frame
Progression free survival rate Overall survival rate Complications Cosmetic evaluation

Countries

Japan

Contacts

Public ContactRyoichi Yoshimura

Tokyo Medical and Dental University Hospital Department of Radiation Therapeutics and Oncology

ysmrmrad@tmd.ac.jp03-5803-5311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026