NCT04158843

Brief Summary

A Randomized, Open Label, Phase III Trial to Evaluate Radical Local Treatment versus Palliative Treatment for Breast Cancer Patients with Primary Ipsilateral Humerus or Sternum Oligometastasis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
8mo left

Started May 2020

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
May 2020Dec 2026

First Submitted

Initial submission to the registry

November 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

May 9, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

November 7, 2019

Last Update Submit

May 9, 2020

Conditions

Breast CancerOligometastasis

Keywords

Breast CancerOligometastasisHumerusSternum

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    PFS is defined as time from randomization to disease progression or death, whichever occurs first

    4 years

Secondary Outcomes (2)

  • Overall Survival (OS)

    4 years

  • Patient Reported Outcomes

    4 years

Study Arms (2)

Radical local treatment

EXPERIMENTAL

Radical resection is performed, and the cutting edge is negative, or radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). Systemic endocrine therapy and targeted therapy are allowed after radical local therapy. However, whether systemic chemotherapy should be used is determined by clinicians according to clinical experience or guidelines.

Procedure: Radical resectionRadiation: Radical radiotherapy

Palliative treatment

ACTIVE COMPARATOR

No radical surgical resection or radical surgical resection or radiotherapy is performed in this group. But palliative internal fixation or radiotherapy for pain relief is permitted. Moreover, systemic chemotherapy, endocrine therapy and targeted therapy are allowed.

Other: Palliative treatment

Interventions

Radical resectionPROCEDURE

Radical resection is performed, and the cutting edge is negative.

Radical local treatment
Radical radiotherapyRADIATION

Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).

Radical local treatment
Palliative treatmentOTHER

Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy

Palliative treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients provided written informed consent
  • Women aged 18-75 years old
  • Histologically confirmed breast cancer and after radical mastectomy
  • Patients of breast cancer with ipsilateral humerus or sternum oligometastasis, and there is no imaging evidence of other site metastases
  • Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments
  • Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization
  • Alanine aminotransferase (ALT) \</= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) \</= 2.5 × ULN prior to randomization
  • Total bilirubin (TBIL) \</= 1.25 × ULN
  • Alkaline phosphatase (ALK) \</= 2.5 × ULN
  • Gamma glutamyl transpeptidase (GGT) \</= 2.5 × ULN
  • Albumin \>/= 30g/L
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
  • Women of child-bearing age should take effective contraceptive measures
  • Serum total bilirubin (TBil) \</= 1.5 × ULN
  • Serum creatinine (Scr) \</= 1.5 × ULN
  • +1 more criteria

You may not qualify if:

  • Without radical mastectomy of the primary breast lesions
  • No radical resection or radiotherapy is possible for metastatic lesions
  • Other site metastases except ipsilateral humerus or sternum are present
  • With multiple metastatic lesions
  • Any other current malignancy or malignancy diagnosed within the past five years (other than carcinoma in situ or stage Ia carcinoma of the cervix, skin basal cell carcinoma and papillary thyroid carcinoma at early stage)
  • Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration.
  • History of participating any other clinical trials within 30 days prior to randomization
  • Known unable to tolerate humerus or sternal surgery or radical radiotherapy
  • Pregnancy or lactation
  • Current severe systemic disease (for example, clinically significant cardiovascular, pulmonary, or renal disease)
  • Legal incompetence or limitation.
  • Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)

Hangzhou, Zhejiang, 310000, China

RECRUITING

Jiaxing Second Hospital

Jiaxing, Zhejiang, 314000, China

NOT YET RECRUITING

The Central Hospital of Lishui

Lishui, Zhejiang, 323000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Xiaobo Yan, MD

    The Second Affiliated Hospital of Zhejiang University School of Medicidne

    STUDY DIRECTOR

Central Study Contacts

xuexin he, MD

CONTACT

+86-18329139569xuexinhe@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 12, 2019

Study Start

May 9, 2020

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

CN(4)