Recruiting
The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.
ClinicalTrials.gov IDNCT06690645
PhaseNot Applicable
Enrollment840
SponsorShengjing Hospital
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.
Interventions
- Other: Exposure: psychological stress status — The assessment of depressive, anxiety or perceived Stress was conducted using PHQ-9, GAD-7 or PSS scale. Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 or a PSS score ≥ 20 were categorized as the stressed group.
Primary outcomes
- Pathologic complete response (pCR) rate (2 years)
Eligibility information
Inclusion Criteria:
* 1.Age ≥ 18 years; 2.Histological and/or cytological diagnosis of breast cancer; 3.Treatment niave patients; 4.To receive standard neoadjuvant therapy; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7.Informed and agreed to participate in the study;
Exclusion Criteria:
* 1\. Breast cancer has not been confirmed through histological or cytological examinations.
2.Other breast cancer conditions that do not receive neoadjuvant therapy. 3.Combined with other malignant tumors. 4.Concurrent acute or chronic psychiatric disorders, along with having received antidepressant or anti-anxiety therapy within the past month.
5.Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.
Study locations
- Shengjing Hospital of China Medical University, Shenyang, Liaoning 110004 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.