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Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis

ConditionsBreast CancerOligometastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
Sponsorxuexin he

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radical resection

    Procedure/Surgery

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

  • Radical radiotherapy

    Radiation

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

  • Palliative treatment

    Other intervention

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

Treatment groups

183 Participants
are divided into 2 treatment groups
Group A: Radical local treatmentExperimental treatment 2 interventions
Group B: Palliative treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS)

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

Time frame
4 years

Secondary outcomes

1

Overall Survival (OS)

OS is defined as time from randomization to death for any cause. If there is no death reported for a subject before the date cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive. For patients who had not died up to the cut-off date, the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomization date.

Time frame
4 years
2

Patient Reported Outcomes

Breast cancer specific health treatment related quality of life and general health status (Functional Assessment of Cancer Therapy-Breast (FACT-B) \[version 4\])

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

xuexin he

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor institution

Source ClinicalTrials.gov
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