A Prospective Cohort Study Comparing Disparity in Surgical Procedure (Wide Local Excision Only vs Any Other Surgery Procedures) Among the Elderly Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Qiang Sun，Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04426136
• Other study ID #: PUMCH-2020-EBC
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: June 2027

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: Qiang Sun, Professor
• Phone: 008613811669255
• Email: sunqiangpumc[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The incidence and mortality rates of breast cancer are still increasing in both developing and developed countries. The number of women ≥70 years who are affected by breast cancer (BC) worldwide is also on the increase. Based on the largest population and increasing aging, BC is also rapidly increasing among the elderly in China. According to the epidemiological profile data regarding BC in China, the second onset age peak of BC morbidity occurred after 70 years old and in 2020, the proportion of patients older than 65 is expected to exceed one-fifth and reach 27.0% by 2030. However, some controversies remain to be resolved due to the lack of high quality evidence. The tumor biological behavior, treatment choice and treatment tolerance among the elderly prominently differ from their young counterparts. Besides, they are rarely enrolled in large-scale randomized clinical trials or prospective cohort studies and the results are obtained mainly from retrospective studies. Also, frequent deviations from the standard guidelines lead to insufficient or excessive treatments, though the so-called standard guidelines are based on the clinicopathological characteristics and research findings among the younger BC patients. Studies focusing on the global population confirmed that the biological behavior of tumors among elderly patients was more favorable compared with younger patients but did not transform into survival benefits eventually. Numerous prospective, randomized trials have demonstrated that breast conserving surgery (BCS), consisting of segmental mastectomy and radiation treatment with or without axillary lymph node dissection (ALND), is equivalent to mastectomy in terms of overall survival (OS) and disease free survival (DFS) for patients with early stage breast carcinoma. Presentation of the ACOZOG-Z011 study results in 2011 resulted in a downward trend in the use of a completion axillary lymph node dissection in early breast cancer patients with 1-2 positive sentinel lymph nodes (SLN), treated with wide local excision (WLE) and whole breast irradiation. However, there is little evidence regarding the optimal axillary treatment in elderly breast cancer patients, since these patients are often excluded from clinical trials. We had done a retrospective study of breast cancer in the elderly, which demonstrated that those who with complex comorbidities receiving wide local excision merely were about 1.5 times more than those who without (71.2% vs 46.0%, p＜0.001). However, it is paradoxical that, on the one hand, the risk of dying from breast cancer may increase if patients do not receive the standard treatment; on the other hand, they could not live long enough to benefit or even suffer more from the standard treatment. The key is to figure out who they are. Given the high proportion of patients treated only with WLE, we believe that it is important to compare the effects of different surgical procedures on prognosis among the elderly BC patient in a prospective cohort study, to be more specific, comparing the WLE versus any other surgical procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of breast cancer

• Received surgical treatment in this institution

• Specific surgical method data available

• Demographic and pathological data available

• No clear evidence of distant metastasis

• Agree to participate in the trial and receive long-term follow-up

Exclusion Criteria:

• Being intolerant of surgical treatment

• Distant metastases have been merged

• Patients who had simultaneous bilateral breast cancer

• Follow-up interval being less than 12 months except reaching endpoints of observation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Elderly Patient
• Surgery
• Survival Outcomes
• Wide Local Excision

Locations

Country	Name	City	State
China	Department of Breast Surgery,Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	the time interval from surgery to disease recurrence or metastasis or considered as still alive at the observation deadline or missed during follow-up	From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months
Primary	overall survival	the time interval from surgery to all cause death or considered as still alive at the observation deadline or missed during follow-up	From date of surgery until the date of death from any cause, assessed up to 72 months
Primary	breast cancer-specific survival	the time interval from surgery to breast cancer related death or considered as still alive at the observation deadline or missed during follow-up	From date of surgery until the date of death from breast cancer related cause, assessed up to 72 months