Basket study for oligo-metastatic breast cancer - ANISE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 May 2024 → ongoing

Decision date (initial)

2025-10-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca/ Daiichi Sankyo

External identifiers

EU CT number

2023-505039-11-00

ClinicalTrials.gov

NCT05982678

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To determine the clinical efficacy of T-DXd as part of multi-modality treatment in patients with HER2-positive oligo-metastatic breast cancer.

Secondary objectives 2

1. To determine the efficacy of T-DXd as part of multi-modality treatment in patients with HER2-positive oligo-metastatic breast cancer in achieving a clinical response along with clearance of ctDNA.
2. To evaluate feasibility, safety and tolerability of T-DXD as part of a multi-modality approach.

Conditions and MedDRA coding

breast cancer, HER2-positive, oligometastatic disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and/or amplification by ISH)
2. Histologic or cytologic proof of breast cancer metastases (at least one lesion)
3. Histologic determination of level of ER-expression
4. Oligo-metastatic disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to five, either in one organ or in 2-5 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion. Pleuritis carcinomatosa, miliary spread of metastases (even within one organ), or peritoneal spread of metastases rules out oligo-metastatic disease and is not allowed. Initial staging by PET-CT (whole body) and MRI of breast and brain are mandatory, as is MRI liver or spine and pelvis in case of liver or bone metastases respectively.
5. In case of recurrent disease, a disease-free interval of 24 months
6. Measurable disease according to RECIST1.1
7. Patients must be at least 18 years of age and be able to give written informed consent and comply with study procedures.
8. World Health Organization (WHO) performance status 0 or 1

Exclusion criteria 5

1. Prior line of therapy for metastatic disease. Exceptions are endocrine therapy or radiation considered to be part of the curative treatment, within 3 months before enrolment
2. Leptomeningeal disease or central nervous metastases
3. Clinically relevant obstruction or compression of spinal cord, central nervous, gastro-intestinal or cardiovascular system, that cannot be alleviated before start of treatment.
4. Other malignancy, unless treated with curative intention and a long-term survival probability of >95%, including in-situ or pre-malignant lesions.
5. Current or planned pregnancy nor ova or sperm donation and willingness to stop breastfeeding during treatment and wash-out period of the investigational product

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete radiologic response as defined by RECIST1.1

Secondary endpoints 7

1. Complete radiologic response as defined by RECIST1.1 along with clearance of ctDNA
2. PFS as defined by RECIST 1.1.
3. Pathological complete response in patients undergoing resection of primary tumor and/or metastatic lesions after neo-adjuvant treatment
4. Complete metabolic response as defined by EORTC guidelines
5. Preplanned loco-regional treatment performed without treatment related delay (window of 3 weeks)
6. Incidence and severity of adverse events (CTCAE v5.0) until 30 days after last treatment administration. Incidence and severity of interstitial lung disease (ILD)
7. Incidence and severity of adverse events grade ≥3 (CTCAE v5.0 or Clavien-Dindo in case of surgical resection) until 30 days after last treatment administration in relation to local therapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Sponsor organisation

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Contact name

Marleen Kok

Public contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Contact name

Marleen Kok

Locations

5 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications