Overview

High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer

Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
Female
Summary
This study investigates the effect of high-dose alkylating chemotherapy compared with standard chemotherapy as part of a multimodality treatment approach in patients with oligo-metastatic breast cancer harboring homologous recombination deficiency.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Netherlands Cancer Institute
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Cyclophosphamide
Docetaxel
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Paclitaxel
Thiotepa
Criteria
Inclusion Criteria:

1. Histologically or cytologically confirmed infiltrating breast cancer

2. Oligometastatic disease defined as one to three distant metastatic lesions, with or
without primary tumor, local recurrence, or locoregional lymph node metastases,
including the ipsilateral axillary, parasternal, and periclavicular regions. All
lesions must be amenable to resection or radiotherapy with curative intent. Staging
examinations must have included a PET-CT-scan and a MRI of the liver in case of liver
metastases. Clustered lymph nodes that can be irradiated with curative intent in a
single field are defined as a single lesion. Histologic or cytologic confirmation of
at least one distant metastatic lesion is required.

3. No prior line of chemotherapy for metastatic disease (a maximum of 3 months of
palliative endocrine therapy is allowed).

4. The tumor must be HER2-negative (either score 0 or 1 at immunohistochemistry or
negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry).

5. The tumor is deficient in homologous recombination and/or the patient has a
deleterious germline BRCA1 or BRCA2 mutation.

6. At least stable disease of all tumor lesions after three courses of induction
chemotherapy

7. Age ≥18 years

8. World Health Organisation (WHO) performance status 0 or 1

9. Adequate bone marrow function (ANC ≥1.0 x 109/l, platelets ≥100 x 109/l)

10. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal)

11. Adequate renal function (creatinine clearance ≥60 ml/min)

12. If clinically recommended echocardiography, MUGA, or MRI to evaluate if LVEF ≥50%;

13. Signed written informed consent

14. Able to comply with the protocol

Exclusion Criteria:

- No malignancy other than breast cancer, unless treated with curative intent without
the use of chemotherapy or radiation therapy

- No current pregnancy or breastfeeding. Women of childbearing potential must use
adequate contraceptive protection.

- No concurrent anti-cancer treatment or investigational drugs