The aim of this study is to find out how long the disease remains stable if we treat the 1-2 growing metastasis(s) locally by removing or irradiating/heating them, while continuing the treatment with your current drugs (anti-hormonal therapy,…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate efficacy as progression- free survival at 6 months (PFS-6)
Secondary outcome
o Evaluate PFS-6 separately for breast cancer subtypes: ER+/HER2- vs. HER2+ vs.
TN
o Evaluate PFS separately for
- breast cancer subtype
- localization of progressive lesion
o Evaluate PFS-6 separately for localization of progressive lesion:
locoregional vs. cranial vs. visceral vs. bone
o Evaluate overall survival (OS)
o Separate analysis for breast cancer subtypes and localization of progressive
lesion
o Evaluate time to next line of systemic therapy
o Separate analysis for breast cancer subtypes and localization of progressive
lesion
o Evaluate number of patients who develop *visceral crisis*
o Local control rate of lesion treated with LAT at 12 months
o Evaluate complications due to LAT
o To evaluate quality of life (QoL)
Background summary
Studies in non-small cell lung cancer, renal cell carcinoma and
gastrointestinal carcinoma have shown that patient could remain on the same
treatment for valuable time (7-10 months). Additionally, PFS was improved after
Local Ablative Treatment (LAT), with different modalities, for the
oligoprogressive lesions compared to historical controls or patient switching
to a new line of therapy.
If LAT controls the deviant lesion(s), the indication to switch to the next
line of systemic therapy is not present anymore. Patients may continue the same
systemic therapy, and this might result in extended time in which the patient
benefits from systemic therapy.
Study objective
The aim of this study is to find out how long the disease remains stable if we
treat the 1-2 growing metastasis(s) locally by removing or irradiating/heating
them, while continuing the treatment with your current drugs (anti-hormonal
therapy, chemotherapy, targeted therapy and/or immunotherapy).
Study design
Single-arm, Phase II, open label, multi-center study
Intervention
Systemic treatment administration will continue as before inclusion in the
study.
The oligo progressive lesion(s) will be treated with radiotherapy, surgery or
intervention radiology
depending on which type of LAT that is best suited for the lesion
Study burden and risks
Subjects are at risk of bruising and pain from (optional) biopsies.
There is a risk of side effects from the local treatment of the oligo
metatases.
This approach, in which the growing metastasis(s) is treated locally while
continuing current systemic therapy, can help control the disease for longer.
As a result, other treatment options remain available for longer as the disease
progresses.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
o Histologically confirmed infiltrating breast cancer
o Metastatic breast cancer
o Oligoprogression defined as one or two distant metastatic lesions, limited to
one organ
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 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05301881 |
| CCMO | NL79293.031.21 |