Clinical trial · Interventional
Chronic Toxicities Related to Treatment in Patients With Localized Cancer
A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer
- 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 aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored furtherwise, fist of all in lung cancer. The project will include four specific aims : 1. To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …) 2. To describe incidence, clinical presentation, and outcome of chronic toxicities. 3. To describe the psychological, the social and the economic impacts of chronic toxicities. 4. To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria. The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one. Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)
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 |
|---|---|---|---|
| Breast Cancer Nos Metastatic Recurrent | — | UNRESOLVED | — |
| Early Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- breast cancer treatment + blood sampling
- description
- Standard treatment of breast cancer with intervention : samples collection
- interventionNames
- Procedure: blood sampling
Primary outcomes (1)
- measure
- Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer
- timeFrame
- 8 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
CANTO - Breast Inclusion Criteria: * Women, * Aged 18 years and over, * With an invasive breast cancer diagnosed by cytology or histology, * No clinical evidence of metastasis at the time of inclusion, * Untreated including scored for breast cancer surgery in progress, * Patient receiving a social security system, * Patient mastering the French language, * Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage. * (Since february 2022) Patient : 1. Age \< 45 years at diagnostic 2. Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2- 3. Or Eligible to Pembrozilumab, Olaparib, TDM1, Abemaciclib or Ribociclib Exclusion Criteria: * Metastatic breast cancer, * Local recurrence of breast cancer, * History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix, * Already received treatment for breast cancer ongoing, * Blood transfusion performed for less than six months, * Persons deprived of liberty or under supervision (including guardianship). CANTO - Lung Inclusion Criteria: * Aged 18 years and over, Having lung cancer diagnosed by cytology or histology or suspected cancer of the lung, * Tumor cTX to cT4, cN0-3, * No clinical evidence of metastasis at the time of inclusion (patients with metastases on extension assessment within 6 months following diagnosis will be removed from the study), * Eligible for curative treatment by surgery or radiotherapy \* (note patients treated with exclusive chemotherapy, exclusive radiotherapy or exclusive stereotactic radiotherapy will be out of study) * Lack of treatment received for current lung cancer, including surgical treatment * Patient benefiting from a social protection scheme, * Patient mastering the French language, * Free and informed consent for additional biological samples, the different questionnaires and the collection of information on resource consumption. Exclusion Criteria: * Metastatic lung cancer, * Local relapse of lung cancer, * History of cancer within 3 years prior to study entry other than basal cell cutaneous or epithelioma in situ of the cervix, * Treatment already received for current lung cancer, * Blood transfusion carried out less than 6 months ago, * Persons deprived of liberty or under guardianship (including curatorship).
References
Publications (22)
- DERIVEDVignot S, Drouet Y, Di Meglio A, Martin AL, Gaudin C, Bertaut A, Fournier M, Jacot W, Cheymol C, Kieffer A, Tarpin C, Lerebours F, Caux C, Boyault S, Menetrier-Caux C, Tredan O. Prognostic value of lymphopenia in early breast cancer: learnings from the prospective CANTO cohort. Breast Cancer Res. 2026 Jun 9. doi: 10.1186/s13058-026-02315-7. Online ahead of print. PMID 42265714
- DERIVEDRuiz De Azua G, Vaz-Luis I, Bovagnet T, Di Meglio A, Havas J, Caumette E, Martin E, Pistilli B, Coutant C, Cottu P, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Rouzier R, Martin AL, Everhard S, Dumas A, Menvielle G. Perceived discrimination at work: examining social, health and work-related factors as determinants among breast cancer survivors - evidence from the prospective CANTO cohort. J Epidemiol Community Health. 2022 Oct 10;76(11):918-924. doi: 10.1136/jech-2021-218331. PMID 41877347
- DERIVEDBidard FC, Gessain G, Bachelot T, Frechin L, Vincent-Salomon A, Drubay D, Lemonnier J, Walter T, Penault-Llorca F, Martin AL, Gaudin C, Bichat A, Sassi F, Berlemont S, Chavez-MacGregor M, Rugo HS, Badoual C, Pistilli B, Ribeiro J, Di Meglio A, Lacroix-Triki M, Vaz Luis I, Lerousseau M, Andre F. Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay. J Clin Oncol. 2025 Oct;43(28):3090-3101. doi: 10.1200/JCO-25-00742. Epub 2025 Aug 22. PMID 40845255
- DERIVEDGiugliano F, Bertaut A, Blanc J, Martin AL, Gaudin C, Fournier M, Kieffer A, Sauterey B, Levy C, Campone M, Tarpin C, Lerebours F, Mouret-Reynier MA, Curigliano G, Andre F, Pistilli B, Rassy E. Characteristics, treatment patterns and survival of patients with high-risk early hormone receptor-positive breast cancer in French real-world settings: an exploratory study of the CANTO cohort. ESMO Open. 2024 Dec;9(12):103994. doi: 10.1016/j.esmoop.2024.103994. Epub 2024 Nov 28. PMID 39612621
- DERIVEDPagliuca M, Havas J, Thomas E, Drouet Y, Soldato D, Franzoi MA, Ribeiro J, Chiodi CK, Gillanders E, Pistilli B, Menvielle G, Joly F, Lerebours F, Rigal O, Petit T, Giacchetti S, Dalenc F, Wassermann J, Arsene O, Martin AL, Everhard S, Tredan O, Boyault S, De Laurentiis M, Viari A, Deleuze JF, Bertaut A, Andre F, Vaz-Luis I, Di Meglio A. Long-term behavioral symptom clusters among survivors of early-stage breast cancer: Development and validation of a predictive model. J Natl Cancer Inst. 2025 Jan 1;117(1):89-102. doi: 10.1093/jnci/djae222.