Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer

NCT06210347 | Unknown

• 1 other identifier: breast cancer and NAC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to identify patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

  Patterns of relapse after Neoadjuvant Chemotherapy (NAC) in breast cancer patients to refine follow up recommendations.

  2 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out at SECI between 2018 and 2022 . All cases with inclusion criteria will be included .

You may qualify if:

• Female patients aged \>= 18
• Pathologically proved breast cancer
• PS 0-1 (ECOG)
• Patients indicated to receive NAC

You may not qualify if:

• Patients with metastatic disease at diagnosis
• Patients who did not undergo subsequent curative intent surgery
• Those who received Neoadjuvant hormonal treatment
• Those that had incomplete treatment information

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 2023 Apr 1;41(10):1795-1808. doi: 10.1200/JCO.22.02571.

  PMID: 36989610 BACKGROUND

• van der Hage JA, van de Velde CJ, Julien JP, Tubiana-Hulin M, Vandervelden C, Duchateau L. Preoperative chemotherapy in primary operable breast cancer: results from the European Organization for Research and Treatment of Cancer trial 10902. J Clin Oncol. 2001 Nov 15;19(22):4224-37. doi: 10.1200/JCO.2001.19.22.4224.

  PMID: 11709566 BACKGROUND

• Mauri D, Pavlidis N, Ioannidis JP. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis. J Natl Cancer Inst. 2005 Feb 2;97(3):188-94. doi: 10.1093/jnci/dji021.

  PMID: 15687361 BACKGROUND

• Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. Lancet Oncol. 2018 Jan;19(1):27-39. doi: 10.1016/S1470-2045(17)30777-5. Epub 2017 Dec 11.

  PMID: 29242041 BACKGROUND

• Kong X, Moran MS, Zhang N, Haffty B, Yang Q. Meta-analysis confirms achieving pathological complete response after neoadjuvant chemotherapy predicts favourable prognosis for breast cancer patients. Eur J Cancer. 2011 Sep;47(14):2084-90. doi: 10.1016/j.ejca.2011.06.014. Epub 2011 Jul 5.

  PMID: 21737257 BACKGROUND

• Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

  PMID: 24529560 BACKGROUND

• Tanioka M, Shimizu C, Yonemori K, Yoshimura K, Tamura K, Kouno T, Ando M, Katsumata N, Tsuda H, Kinoshita T, Fujiwara Y. Predictors of recurrence in breast cancer patients with a pathologic complete response after neoadjuvant chemotherapy. Br J Cancer. 2010 Jul 27;103(3):297-302. doi: 10.1038/sj.bjc.6605769. Epub 2010 Jul 6.

  PMID: 20606681 BACKGROUND

• Wolmark N, Wang J, Mamounas E, Bryant J, Fisher B. Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18. J Natl Cancer Inst Monogr. 2001;(30):96-102. doi: 10.1093/oxfordjournals.jncimonographs.a003469.

  PMID: 11773300 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nour Salah, Master

CONTACT

0115 245 9725; dr.noursalah97@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer and Implications for Follow up in Clinical Practice

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01