Chronic Toxicities Related to Treatment in Patients With Localized Cancer

NCT01993498 | Recruiting

• 2 other identifiers: UC-0140/1103 CANTO2011-A01095-36
• Study Type: interventional
• Target: 14,750
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To describe incidence, clinical presentation, and outcome of chronic toxicities.
3. 3.To describe the psychological, the social and the economic impacts of chronic toxicities.
4. 4.To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.

Conditions

Breast Cancer Nos Metastatic Recurrent; Early Lung Cancer

Keywords

cancer toxicities; cohort; breast cancer; early lung cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer

  8 years

Study Arms (1)

breast cancer treatment + blood sampling

OTHER

Standard treatment of breast cancer with intervention : samples collection

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

blood samples collection

breast cancer treatment + blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women,
• Aged 18 years and over,
• With an invasive breast cancer diagnosed by cytology or histology,
• 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 :
• Age \< 45 years at diagnostic
• Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2-
• Or Eligible to Pembrozilumab, Olaparib, TDM1, Abemaciclib or Ribociclib

You may not qualify if:

• 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
• 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,
• 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.
• Metastatic lung cancer,

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (1)

Gustave roussy

Villejuif, 94805, France

RECRUITING

Related Publications (19)

• Bidard 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 DERIVED

• Giugliano 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 DERIVED

• Pagliuca 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.

  PMID: 39250750 DERIVED

• Sandoval JL, Franzoi MA, di Meglio A, Ferreira AR, Viansone A, Andre F, Martin AL, Everhard S, Jouannaud C, Fournier M, Rouanet P, Vanlemmens L, Dhaini-Merimeche A, Sauterey B, Cottu P, Levy C, Stringhini S, Guessous I, Vaz-Luis I, Menvielle G. Magnitude and Temporal Variations of Socioeconomic Inequalities in the Quality of Life After Early Breast Cancer: Results From the Multicentric French CANTO Cohort. J Clin Oncol. 2024 Aug 20;42(24):2908-2917. doi: 10.1200/JCO.23.02099. Epub 2024 Jun 18.

  PMID: 38889372 DERIVED

• Balazard F, Bertaut A, Bordet E, Mulard S, Blanc J, Briot N, Paux G, Dhaini Merimeche A, Rigal O, Coutant C, Fournier M, Jouannaud C, Soulie P, Lerebours F, Cottu PH, Tredan O, Vanlemmens L, Levy C, Mouret-Reynier MA, Campone M, Brady KJS, Sasane M, Rice M, Coulouvrat C, Martin AL, Jacquet A, Vaz-Luis I, Herold C, Pistilli B. Adjuvant endocrine therapy uptake, toxicity, quality of life, and prediction of early discontinuation. J Natl Cancer Inst. 2023 Sep 7;115(9):1099-1108. doi: 10.1093/jnci/djad109.

  PMID: 37434306 DERIVED

• Ghannam Y, Di Meglio A, Sarrade T, Jacquet A, Everhard S, Kirova Y, Peignaux K, Guilbert P, Charra-Brunaud C, Blanchecotte J, Bochaton OF, Pasquier D, Racadot S, Bourgier C, Geffrelot J, Benyoucef A, Paris F, Auzac G, Luis IV, Rivera S. Impact of radiation therapy on fatigue at 1 year in breast cancer survivors in the prospective multicentre CANcer TOxicity cohort. Eur J Cancer. 2022 Dec;177:143-153. doi: 10.1016/j.ejca.2022.09.026. Epub 2022 Oct 10.

  PMID: 36356418 DERIVED

• Soldato D, Havas J, Crane TE, Presti D, Lapidari P, Rassy N, Pistilli B, Martin E, Del Mastro L, Martin AL, Jacquet A, Coutant C, Cottu P, Merimeche A, Lerebours F, Tredan O, Vanlemmens L, Andre F, Vaz-Luis I, Di Meglio A. Coffee and tea consumption, patient-reported, and clinical outcomes in a longitudinal study of patients with breast cancer. Cancer. 2022 Oct 1;128(19):3552-3563. doi: 10.1002/cncr.34401. Epub 2022 Aug 1.

  PMID: 35913436 DERIVED

• Presti D, Havas J, Soldato D, Lapidari P, Martin E, Pistilli B, Jouannaud C, Emile G, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Campone M, Guillermet S, Martin AL, Everhard S, Di Meglio A. Factors associated with enrolment in clinical trials among women with early-stage breast cancer. ESMO Open. 2022 Jun;7(3):100513. doi: 10.1016/j.esmoop.2022.100513. Epub 2022 Jun 17.

  PMID: 35724624 DERIVED

• Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.

  PMID: 35715631 DERIVED

• Di Meglio A, Havas J, Gbenou AS, Martin E, El-Mouhebb M, Pistilli B, Menvielle G, Dumas A, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Joly F, Delaloge S, Ganz PA, Andre F, Partridge AH, Jones LW, Michiels S, Vaz-Luis I. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy. J Clin Oncol. 2022 Sep 20;40(27):3190-3204. doi: 10.1200/JCO.21.00277. Epub 2022 Apr 21.

  PMID: 35446677 DERIVED

• Vaz-Luis I, Di Meglio A, Havas J, El-Mouhebb M, Lapidari P, Presti D, Soldato D, Pistilli B, Dumas A, Menvielle G, Charles C, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Dauchy S, Delaloge S, Lin NU, Ganz PA, Partridge AH, Andre F, Michiels S. Long-Term Longitudinal Patterns of Patient-Reported Fatigue After Breast Cancer: A Group-Based Trajectory Analysis. J Clin Oncol. 2022 Jul 1;40(19):2148-2162. doi: 10.1200/JCO.21.01958. Epub 2022 Mar 15.

  PMID: 35290073 DERIVED

• Di Meglio A, Charles C, Martin E, Havas J, Gbenou A, Flaysakier JD, Martin AL, Everhard S, Laas E, Chopin N, Vanlemmens L, Jouannaud C, Levy C, Rigal O, Fournier M, Soulie P, Scotte F, Pistilli B, Dumas A, Menvielle G, Andre F, Michiels S, Dauchy S, Vaz-Luis I. Uptake of Recommendations for Posttreatment Cancer-Related Fatigue Among Breast Cancer Survivors. J Natl Compr Canc Netw. 2022 Feb 7;20(13). doi: 10.6004/jnccn.2021.7051.

  PMID: 35130491 DERIVED

• Di Meglio A, Havas J, Soldato D, Presti D, Martin E, Pistilli B, Menvielle G, Dumas A, Charles C, Everhard S, Martin AL, Coutant C, Tarpin C, Vanlemmens L, Levy C, Rigal O, Delaloge S, Lin NU, Ganz PA, Partridge AH, Andre F, Michiels S, Vaz-Luis I. Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care. J Clin Oncol. 2022 Apr 1;40(10):1111-1123. doi: 10.1200/JCO.21.01252. Epub 2022 Jan 21.

  PMID: 35061509 DERIVED

• Caumette E, Vaz-Luis I, Pinto S, Havas J, Bovagnet T, Ruiz de Azua G, Di Meglio A, Martin AL, Everhard S, Cottu P, Vanlemmens L, Jouannaud C, Lerebours F, Dumas A, Menvielle G. The Challenge of Return to Work after Breast Cancer: The Role of Family Situation, CANTO Cohort. Curr Oncol. 2021 Oct 1;28(5):3866-3875. doi: 10.3390/curroncol28050330.

  PMID: 34677248 DERIVED

• Di Meglio A, Gbenou AS, Martin E, Pistilli B, Ligibel JA, Crane TE, Flaysakier JD, Minvielle E, Vanlemmens L, Guenancia C, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Boiffard F, Guillermet S, Everhard S, Martin AL, Giacchetti S, Petit T, Dalenc F, Rouanet P, Arnaud A, Andre F, Vaz-Luis I. Unhealthy behaviors after breast cancer: Capitalizing on a teachable moment to promote lifestyle improvements. Cancer. 2021 Aug 1;127(15):2774-2787. doi: 10.1002/cncr.33565. Epub 2021 Apr 22.

  PMID: 33887074 DERIVED

• Di Meglio A, Menvielle G, Dumas A, Gbenou A, Pinto S, Bovagnet T, Martin E, Ferreira AR, Vanlemmens L, Arsene O, Ibrahim M, Wassermann J, Martin AL, Lemonnier J, Del Mastro L, Jones LW, Partridge AH, Ligibel JA, Andre F, Michiels S, Vaz Luis I. Body weight and return to work among survivors of early-stage breast cancer. ESMO Open. 2020 Nov;5(6):e000908. doi: 10.1136/esmoopen-2020-000908.

  PMID: 33172957 DERIVED

• Pistilli B, Paci A, Ferreira AR, Di Meglio A, Poinsignon V, Bardet A, Menvielle G, Dumas A, Pinto S, Dauchy S, Fasse L, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Jouannaud C, Levy C, Everhard S, Arveux P, Martin AL, Dima A, Lin NU, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Serum Detection of Nonadherence to Adjuvant Tamoxifen and Breast Cancer Recurrence Risk. J Clin Oncol. 2020 Aug 20;38(24):2762-2772. doi: 10.1200/JCO.19.01758. Epub 2020 Jun 22.

  PMID: 32568632 DERIVED

• Kabore EG, Guenancia C, Vaz-Luis I, Di Meglio A, Pistilli B, Coutant C, Cottu P, Lesur A, Petit T, Dalenc F, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Boileau-Jolimoy G, Martin AL, Lemonnier J, Andre F, Arveux P. Association of body mass index and cardiotoxicity related to anthracyclines and trastuzumab in early breast cancer: French CANTO cohort study. PLoS Med. 2019 Dec 23;16(12):e1002989. doi: 10.1371/journal.pmed.1002989. eCollection 2019 Dec.

  PMID: 31869400 DERIVED

• Ferreira AR, Di Meglio A, Pistilli B, Gbenou AS, El-Mouhebb M, Dauchy S, Charles C, Joly F, Everhard S, Lambertini M, Coutant C, Cottu P, Lerebours F, Petit T, Dalenc F, Rouanet P, Arnaud A, Martin A, Berille J, Ganz PA, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Differential impact of endocrine therapy and chemotherapy on quality of life of breast cancer survivors: a prospective patient-reported outcomes analysis. Ann Oncol. 2019 Nov 1;30(11):1784-1795. doi: 10.1093/annonc/mdz298.

  PMID: 31591636 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Inès VAZ-LUIS, Professor

  Gustave Roussy - Villejuif

  STUDY DIRECTOR

Central Study Contacts

Catherine Gaudin

CONTACT

(0)6 71 48 27 76; c-gaudin@unicancer.fr

Anne Laure Martin

CONTACT

(0)6 18 38 96 29; al-martin@unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For each patient, in addition to standard medical follow-up collected at selection, and yearly after acute treatment cancer phase during 5 years, the CANTO-specific follow-up includes 16 patient-reported questionnaires.

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 25, 2013
• Study Start: February 20, 2012
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
• Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

Locations

FR (1)