Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01781338
Other study ID # WSG-AM06 / ADAPT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 2012
Est. completion date October 2024

Study information

Verified date July 2019
Source West German Study Group
Contact Michael Staedele
Phone +49 2161 566 23
Email wsg@wsg-online.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.


Recruitment information / eligibility

Status Recruiting
Enrollment 4936
Est. completion date October 2024
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)

- Histologically confirmed unilateral primary invasive carcinoma of the breast

- Clinical T1 - T4 (except inflammatory breast cancer)

- All clinical N (cN)

- No clinical evidence for distant metastasis (M0)

- Known HR status and HER2 status (local pathology)

- Tumor block available for central pathology review

- Performance Status ECOG <= 1 or KI >= 80%

- Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients

- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements

- The patient must be accessible for treatment and follow-up

Exclusion Criteria:

- Known hypersensitivity reaction to the compounds or incorporated substances

- Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri

- Non-operable breast cancer including inflammatory breast cancer

- Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor

- Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry

- Male breast cancer

- Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment

- Breast feeding woman

- Sequential breast cancer

- Reasons indicating risk of poor compliance

- Patients not able to consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Induction therapy
The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.

Locations

Country Name City State
Germany Ev. Krankenhaus Bethesda Brustzentrum Niederrhein Moenchengladbach NRW
Germany Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
West German Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Any pre-specified outcome measure is defined within the sub-protocols. Toxicity and cost efficacy are common endpoints of all sub-protocols. Additional "translational research" questions occurring during the trial will be defined in sub-protocols. 8 years
Primary Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS=11 In order to identify patients that are at comparable low risk as hormone receptor positive, HER2 negative patients with low Recurrence Score, any sub-population across the sub-trials will be compared to this risk group. 8 years
Secondary Overall survival 8 years
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Recruiting NCT04574609 - Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment. N/A
Recruiting NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Enrolling by invitation NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Active, not recruiting NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Suspended NCT04102436 - Non-Viral TCR Gene Therapy Phase 2
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT04190381 - A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy N/A
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Suspended NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2