An observational study to evaluate the prevalence of a cancer immunotherapy target and its role in patients with triple-negative breast cancer treated with systemic therapy (VANESSA)
| ISRCTN | ISRCTN68770903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68770903 |
| IRAS number | 303428 |
| Secondary identifying numbers | MO42921, IRAS 303428, CPMS 50835 |
- Submission date
- 18/09/2021
- Registration date
- 12/01/2022
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
This observational study is also called a secondary data use non-interventional study or medical chart review study, which means that the study looks at medical data and tissue samples that have already been collected as part of routine medical practice.
The purpose of this study is to evaluate the role of a protein called programmed death-ligand 1 (PD-L1) in patients with triple-negative breast cancer (TNBC). Triple-negative breast cancer is a kind of breast cancer that does not have any of the receptors that are commonly found in breast cancer. The PD-L1 protein is found in tissue samples from patients with TNBC. Cells that produce a lot of PD-L1 protein, which are called PD-L1 positive, can partially resist or help the tumor evade the body’s natural immune response. Blocking the PD-L1 protein may help the immune system to stop or reverse the growth of tumors.
The presence of PD-L1 protein in tumor tissue samples can be assessed with a laboratory test called the VENTANA anti-PD-L1 (SP142) assay.
This study will investigate how many patients with TNBC have tumors that are positive for the PD-L1 protein, and how being positive for PD-L1 affects the behavior of the tumor. The study will also assess whether the PD-L1 test results are consistent when measured in different laboratories.
Who can participate?
Patients aged over 18 years with a diagnosis of eTNBC (early or locoregionally advanced TNBC, amenable to treatment with curative intent) or mTNBC (metastatic or locoregionally advanced unresectable TNBC, not amenable to treatment with curative intent) between 1st January 2014 and 31st December 2017, with a documented PD-L1 result.
What does the study involve?
Laboratory tests will be conducted on tissue samples that have already been taken from participants as part of medical routine care. Participants will not undergo any other surgical procedure for this study, and no additional tissue samples will be taken. Only tissue samples that have already been taken from a previous biopsy or surgical procedure can be used and collected by the study doctor.
A piece of body tissue sample will be tested by the local pathology laboratory to measure how much PD-L1 protein is present. The participant’s doctor will also send a small section of the participant’s tissue sample(s) to a study-designated central laboratory where the testing for PD-L1 will be performed.
The Ventana anti-PD-L1 (SP142) laboratory test will be used in both laboratories to measure the expression of the PD-L1 protein. The results of these tests are not intended to be used (as part of this study) to recommend treatment options.
If the patient signs the optional additional consent, testing may involve analysis of the participant’s genome (DNA), the "instruction book" for the cells in the body. Participant’s samples may be tested for inherited or non-inherited genome variations, to allow for exploration of broad health research questions across disease areas. Testing may include analysis of all of body DNA (whole genome sequencing) or analysis of part of participant’s DNA. Analyses of samples from a large number of people may help researchers learn more about breast cancer and other diseases, possible links among diseases, mutations and how they might affect a disease or a person's response to treatment, and new avenues for drug development and personalized therapies
What are the possible benefits and risks of participating?
There is no direct medical benefit to participants from being in this study. The information gained from this study may help researchers and doctors to learn more about how to treat patients with TNBC. Participants and other patients with TNBC or a similar condition may benefit from the results of such research in the future.
The Research Biosample Repository (RBR) tissue sample will be taken from a sample that was collected before this study, so there are no additional risks. Although care is taken to not exhaust the archival tissue blocks, there remains a small risk that the tissue might get used up. There are no additional risks associated with donating participants’ leftover samples to the RBR.
Where is the study run from?
F. Hoffmann-La Roche (Switzerland)
When is the study starting and how long is it expected to run for?
June 2021 to September 2022
Who is funding the study?
F. Hoffmann-La Roche (Switzerland)
Who is the main contact?
Trial Information Support Line
global-roche-genentech-trials@gene.com
Contact information
Public
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 (0)888 662 6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Observational multi-country study with secondary data use (NIS SDU) from two cohorts |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | A multi-country observational retrospective study to evaluate the prevalence of PD-L1 and its role in patients with triple-negative breast cancer treated with systemic therapy (VANESSA) |
| Study hypothesis | To evaluate the prevalence of PD-L1 positivity on primary or metastatic tissue among early TNBC (eTNBC) and metastatic TNBC (mTNBC) patients treated with systemic therapy. |
| Ethics approval(s) | Approved 06/09/2021, Ethics Committee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society (Pilsonu Street 13, Riga, LV- 1002, Latvia; +371 (0)26380055; etikas-komiteja@stradini.lv), ref: 260821-1E (for English version) and 260521-1L (for Latvian version) |
| Condition | Triple-negative breast cancer treated with systemic therapy |
| Intervention | Approximately 2,700 patients with a new diagnosis of eTNBC or mTNBC between 1st January 2014 and 31st December 2017 will be considered for inclusion in this study. Medical/treatment history data will be retrospectively extracted from medical records and archived tissue samples will be analyzed. Archived tumor tissue samples from the primary and/or metastatic lesion will be tested for PD-L1 using the Ventana PD-L1 (SP142) assay. |
| Intervention type | Other |
| Primary outcome measure | PD-L1 positivity, as defined by expression on tumor-infiltrating immune cells covering ≥1% of tumor area by IHC using the Ventana PD-L1 (SP142) assay, measured at a single timepoint |
| Secondary outcome measures | Inter-observer concordance on PD-L1 positivity using the Ventana PD-L1 (SP142) assay between local and central laboratories, measured at a single timepoint |
| Overall study start date | 03/06/2021 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 2700 |
| Participant inclusion criteria | 1. Signed Informed Consent Form, if and as required, according to local laws and regulations 2. Aged ≥18 years at the time of diagnosis 3. Histologically documented TNBC, assessed locally and defined as ER and PR positivity of less than 1% and HER2 IHC0, IHC1+, or IHC2+/ISH-, as determined according to ASCO/CAP guidelines 4. New diagnosis of eTNBC (early or locoregionally advanced TNBC, amenable to treatment with curative intent) or mTNBC (metastatic or locoregionally advanced unresectable TNBC, not amenable to treatment with curative intent) between 1st January 2014 and 31st December 2017 5. Available formalin-fixed paraffin-embedded (FFPE) tumor tissue of good quality based on total and viable tumor content for local and central laboratory PD-L1 testing 6. Documentation of tissue source (primary breast cancer, de novo breast cancer, metastatic tumor location), biopsy or resection, tissue size and tumor content 7. Patients who received any systemic therapy in early-stage disease and/or in metastatic setting 8. Only patients with documented, locally determined PD-L1 status using Ventana PD-L1 (SP142) assay by trained pathologists, will be eligible for central testing and their data will be included in the study analysis |
| Participant exclusion criteria | 1. No available archival tumor tissue for PD-L1 testing 2. Tissue samples of poor quality based on total and viable tumor content and/or bad fixation 3. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable 4. Patients whose tumor tissue is not evaluable for local and central testing |
| Recruitment start date | 30/09/2021 |
| Recruitment end date | 30/09/2022 |
Locations
Countries of recruitment
- Algeria
- Chile
- England
- Finland
- Germany
- India
- Italy
- Kenya
- Korea, South
- Latvia
- Lebanon
- Lithuania
- Morocco
- Peru
- Russian Federation
- Saudi Arabia
- Serbia
- South Africa
- Tunisia
- Türkiye
- United Kingdom
- Viet Nam
Study participating centres
Santiago
3580000
Chile
Annaba
23000
Algeria
Sidi M'Hamed
16000
Algeria
Providencia
Santiago
7500921
Chile
Hämeentie 11
T-Hospital
Turku
20520
Finland
Liebigstr. 26, Haus G
Leipzig
04103
Germany
Langenbeckstraße
Mainz
155131
Germany
Moorenstr. 5
Düsseldorf
40225
Germany
Rohini
Delhi
110085
India
S.P.Road
Secunderabad
500003
India
AIMS Ponekkara P O
Cochin
682041
India
Dr. E Borges Road
Parel East
Parel
Mumbai
400012
India
Oncologia medica 2
Padiglione 41 (ex microbiologia)
Primo Piano Ponente Studio N°7
L.go Rosanna Benzi 10
Genova
16132
Italy
4 piano edificio CORE
Reggio Emilia
42123
Italy
off Limuru Road
P.O. Box 30270
Nairobi
GPO 00100
Kenya
Hipokrata iela 2
Riga
LV-1038
Latvia
Kaunas
50161
Lithuania
Vilnius
LT - 08406
Lithuania
Beirut
-
Lebanon
Beirut
-
Lebanon
Rabat
-
Morocco
BP:1835 Atlas
Avenue Hassan II
Fes
30050
Morocco
Chacarilla del Estanque
Surco
Lima
15038
Peru
Chacarilla del Estanque
Surco
Lima
15038
Peru
Zmeinogorskiy Trakt, 110
Barnaul
656045
Russian Federation
Partizana Zheleznyaka st, 3A
Krasnoyarsk
660022
Russian Federation
Kashirskoe Hwy b.23
Moscow
115478
Russian Federation
Riyadh
11564
Saudi Arabia
Belgrade
11000
Serbia
Sremska Kamenica
21204
Serbia
17 Eton Road
Parktown
Johannesburg
2193
South Africa
Songpa-gu
Seoul
05505
Korea, South
Tunis
1006
Tunisia
Sousse
4000
Tunisia
Kazım Karabekir Cd.
Muratpaşa/Antalya
07100
Türkiye
Sarıçam/Adana
01330
Türkiye
Topkapı
Fatih/İstanbul
34093
Türkiye
Uygulama Merkezi
İskender/Edirne
22030
Türkiye
Muhsin Yazıcıoğlu Cad.
Pendik/İstanbul
34899
Türkiye
3 Queen Mother Square
Poundbury
Dorchester
DT1 3BJ
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Tan Trieu
Thanh Tri
Ha Noi
-
Viet Nam
Ward 7
Binh Thanh district
Ho Chi Minh City
-
Viet Nam
Sponsor information
Industry
Grenzacherstr. 124
Basel
4070
Switzerland
| Phone | +41 (0)61 688 11 11 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about_roche/roche_worldwide.htm |
"ROR" |
https://ror.org/00by1q217 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The participant dataset is not available; this is not required by regulation. |
Editorial Notes
01/02/2022: Internal review.
23/11/2021: Trial's existence confirmed by the Ethics Committee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society.
