COntinue the SaMe systemic therapy after local ablative therapy for Oligo progression in metastatic breast cancer - the COSMO study

Phase 2

Recruiting

Conditions: breast cancer
oligo progression
10006291

Registration Number: NL-OMON54479

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

o Histologically confirmed infiltrating breast cancer
o MBC according to TNM-staging
o Oligoprogression defined as one or two distant metastatic lesions, limited to
one organ
o Oligoprogression should occur during first- or second-line systemic therapy
o Patients should be on systemic therapy for at least 6 months without prior
evidence of progressive disease.
o Lesion(s) must be amenable to resection, radiotherapy or percutaneous
ablation with the intent of local obliteration.
o Age >=18
o World Health Organization (WHO) Performance Status 0 or 1
o Signed written informed consent before patient registration according to
ICH/GCP, and national/local regulations

Exclusion Criteria

o Having received more than two lines of systemic therapy for MBC
o Prior or concurrent other invasive malignancy except basal cell carcinoma of
the skin, unless the other malignancy was treated >=5 years ago with curative
intent without the use of chemotherapy or radiation therapy
o Current pregnancy or breastfeeding. Women of childbearing potential must use
adequate contraceptive protection
o Presence of any medical condition that would place the patient at unusual risk
o Presence of any psychological, familial, sociological, or geographical
condition potentially hampering compliance with the study protocol and
follow-up schedule

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate efficacy as progression- free survival at 6 months (PFS-6)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Evaluate PFS-6 separately for breast cancer subtypes: ER+/HER2- vs. HER2+ vs.<br /><br>TN<br /><br>o Evaluate PFS separately for<br /><br>- breast cancer subtype<br /><br>- localization of progressive lesion<br /><br>o Evaluate PFS-6 separately for localization of progressive lesion:<br /><br>locoregional vs. cranial vs. visceral vs. bone<br /><br>o Evaluate overall survival (OS)<br /><br>o Separate analysis for breast cancer subtypes and localization of progressive<br /><br>lesion<br /><br>o Evaluate time to next line of systemic therapy<br /><br>o Separate analysis for breast cancer subtypes and localization of progressive<br /><br>lesion<br /><br>o Evaluate number of patients who develop visceral crisis<br /><br>o Local control rate of lesion treated with LAT at 12 months<br /><br>o Evaluate complications due to LAT<br /><br>o To evaluate quality of life (QoL)</p><br>