Clinical trial · Interventional
A Study of Surgery and Radiotherapy in People With Breast Cancer
A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]
NCT07053085CI-TRIAL-00111622recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lumpectomy or mastectomy | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care arm
- description
- Continuation of first-line systemic therapy will receive the usual approach (drug therapy). Patients will be assigned to the continuation of first-line systemic therapy for an indefinite period per the standard of care. Escalation of systemic-therapy line is at the discretion of the treating physician per standard of care.
- interventionNames
- Drug: Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
- type
- EXPERIMENTAL
- label
- Consolidation arm
- description
- Patients will receive surgery, locoregional radiation therapy, SBRT, and the usual approach
- interventionNames
- Procedure: Lumpectomy or mastectomy
- Radiation: Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Pathologically-confirmed metastatic breast cancer. * Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration. * HER2-positive breast cancer per CAP/ASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status). * Based on size and location, all metastatic sites can be safely treated with either SBRT or resection. * Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment). * ECOG performance status 0-2; KPS 60-100 Exclusion Criteria: * Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician) * Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment). * Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy. * Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted) * Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered). Inclusion of Underrepresented Populations * Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.
References
Publications (0)
Data not yet available
No reference posted for this study.