RBR-3h369zf Impact of immediate breast reconstruction on time to start chemotherapy and radiotherapy after mastectomy

Date of registration: 03/10/2025 ^(mm/dd/yyyy)
Last approval date : 03/10/2025 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1317-1297

• Public title:

  en

  Impact of immediate breast reconstruction on time to start chemotherapy and radiotherapy after mastectomy

  pt-br

  Impacto da reconstrução mamária imediata no tempo para iniciar a quimioterapia e radioterapia após a mastectomia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 57203622.0.0000.5662
    Issuing authority: Plataforma Brasil
  • 5.584.821
    Issuing authority: Comitê de Ética em Pesquisa do Instituto de Ciências da Saúde da Universidade Federal da Bahia

Sponsors

• Primary sponsor: Hospital Aristides Maltez
• Secondary sponsor:
  • Institution: Universidade Federal do Rio Grande do Sul
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES

Health conditions

• Health conditions:

  en

  Mastectomy

  pt-br

  Mastectomia

• General descriptors for health conditions:

  en

  C04.588.180 Breast Neoplasms

  pt-br

  C04.588.180 Câncer de mama

• Specific descriptors:

  en

  E04.466 Mastectomy

  pt-br

  E04.466 Mastectomia

Interventions

• Interventions:

  en

  A total of 930 women with clinical stage I-III breast cancer undergoing chemotherapy or radiotherapy after mastectomy treated at Aristides Maltez Hospital from January 2018 to December 2022 were included in the study. The cohort consisted of 730 patients with mastectomy without breast reconstruction and 200 with immediate breast reconstruction with implants. The objective was to evaluate whether there was a difference in the time to start the first adjuvant therapy between the two cohorts, using data collected through retrospective review of medical records. The follow-up period consisted of the time of the last surgery for definitive cancer treatment until the date of administration of the first adjuvant therapy. The mean follow-up time was 3 months.

  pt-br

  Um total de 930 mulheres com câncer de mama no estádio clínico I-III submetidas à quimioterapia ou radioterapia após mastectomia atendidas no Hospital Aristides Maltez, no período de janeiro de 2018 a dezembro de 2022, foram incluídas no estudo. A coorte consistiu em 730 pacientes com mastectomia sem reconstrução mamária e 200 com reconstrução mamária imediata com implantes. O objetivo foi avaliar se houve diferença no tempo para iniciar a primeira terapia adjuvante entre as duas coortes, utilizando dados coletados através da revisão retrospectiva dos registros médicos. O período de seguimento consistiu do tempo da última cirurgia para tratamento definitivo do câncer até a data da administração do primeira terapia adjuvante. A média de tempo de seguimento foi de 3 meses.

• Descriptors:

  en

  V03.175.500 Observational Study

  pt-br

  V03.175.500 Estudo observacional

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 01/01/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  930	F	18 Y	0

• Inclusion criteria:

  en

  Women aged 18 years or older; diagnosis of invasive breast carcinoma treated at Aristides Maltez Hospital; clinical staging I, II and III according to the American Joint Committee on Cancer 8th edition; patients undergoing mastectomy only; patients undergoing any type of mastectomy only and mastectomy associated with immediate implant-based breast reconstruction

  pt-br

  Mulheres com 18 anos ou mais; diagnóstico de carcinoma invasivo da mama atendidas no Hospital Aristides Maltez; estadiamento clínico I, II e III de acordo com o American Joint Committee on Cancer 8 edition; pacientes submetidas à mastectomia apenas; pacientes submetidas à qualquer tipo de mastectomia apenas e a mastectomia associada a reconstrução mamária imediata baseada em implante

• Exclusion criteria:

  en

  Diagnosis of local and regional recurrence and distant metastases of breast cancer; diagnosis of de novo stage IV; inflammatory carcinoma; first adjuvant therapy not performed at Aristides Maltez Hospital; prophylactic mastectomy; incomplete neoadjuvant chemotherapy up to the time of mastectomy; tumor progression or clinical non-response to neoadjuvant chemotherapy; bilateral mastectomy

  pt-br

  Diagnóstico de recorrência local, regional e metástases a distância de câncer de mama; diagnóstico de estadio IV de novo; carcinoma inflamatório; primeira terapia adjuvante não realizada no Hospital Aristides Maltez; mastectomia profilática; quimioterapia neoadjuvante incompleta até o momento da mastectomia; progressão tumoral ou não resposta clínica à quimioterapia neoadjuvante; mastectomia bilateral

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  To evaluate the time (days and weeks) after surgery to start adjuvant therapy between groups of mastectomy with and without immediate breast reconstruction.

  pt-br

  Avaliar o tempo (dias e semanas) após cirurgia para iniciar da terapia adjuvante entre os grupos de pacientes mastectomizadas com e sem reconstrução mamária imediata

• Secondary outcomes:

  en

  To assess whether immediate breast reconstruction interferes with the time (days and weeks) to start the first adjuvant therapy

  pt-br

  Avaliar se a reconstrução mamária imediata baseada interfere no tempo (dias e semanas) para o início da primeira terapia adjuvante

Contacts

• Public contact
  • Full name: Lilian de Sá Paz
  • • Address: Av. Dom João VI, nº 332, Brotas
    • City: Salvador / Brazil
    • Zip code: 40285-001
  • Phone: +55 (71) 33576800
  • Email: lilianpazramos@gmail.com
  • Affiliation: Hospital Aristides Maltez
   
• Scientific contact
  • Full name: Lilian de Sá Paz
  • • Address: Av. Dom João VI, nº 332, Brotas
    • City: Salvador / Brazil
    • Zip code: 40285-001
  • Phone: +55 (71) 33576800
  • Email: lilianpazramos@gmail.com
  • Affiliation: Hospital Aristides Maltez
   
• Site contact
  • Full name: Lilian de Sá Paz
  • • Address: Av. Dom João VI, nº 332, Brotas
    • City: Salvador / Brazil
    • Zip code: 40285-001
  • Phone: +55 (71) 33576800
  • Email: lilianpazramos@gmail.com
  • Affiliation: Hospital Aristides Maltez
   

Additional links:

• Download in ICTRP format