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AzTrials

Breast CancerPhase 2ADAPTNCT01815242

Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer

A Phase 2 study testing nab-Paclitaxel, Gemcitabine and Carboplatin in people with Breast Cancer, run by Women's Cancer Study Group GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
nab-Paclitaxel, Gemcitabine and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
1 siteGermany
Study dates
Jun 2013to 15 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 20Show fewer
  • 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
  • Additional Inclusion Criteria for patients receiving chemotherapy:
  • Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment):
  • Leucocytes >= 3.5 10^9/L
  • Platelets >= 100 10^9/L
  • Hemoglobin >= 10 g/dL
  • Total bilirubin <= 1 x ULN
  • ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL
  • Creatinine <= 175 µmol/L (2 mg/dl)
  • LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

Who cannot join

  • 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
Show all 21Show fewer
  • 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
  • Additional Exclusion Criteria for patients receiving chemotherapy:
  • Known polyneuropathy ≥ grade 2
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
  • Uncompensated cardiac function
  • Inadequate organ function including:
  • Leucocytes < 3.5 x 10^9/l
  • Platelets < 100 x 10^9/l
  • Bilirubin above normal limits
  • Alkaline phosphatase > 5 x UNL
  • ASAT and/or ALAT associated with AP > 2.5 x UNL

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

    Mönchengladbach, 41061

Other trials in Germany

About this study

The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01815242
Study groupRoleWhat they receive
Arm AExperimentalnab-Paclitaxel + gemcitabine
Receives: Drug: nab-Paclitaxel; Drug: Gemcitabine
Arm BExperimentalnab-Paclitaxel + carboplatin
Receives: Drug: nab-Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine

    pCR will be measured after 12 weeks of randomized treatment.

    Measured: After 12 weeks of therapy

  2. Comparison: pCR in responders vs. non-responders

    pCR will be measured after 12 weeks of randomized treatment.

    Measured: After 12 weeks of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMar 2015
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815242
Sponsor's protocol ID
WSG-AM06 / ADAPT TN
Acronym
ADAPT
Status last verified
Feb 2025
First submitted
18 Mar 2013
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23958221

  • Korbie D, Stirzaker C, Gluz O, Zu Eulenburg C, Nitz U, Christgen M, Kuemmel S, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Pelz E, Kreipe HH, Clark SJ, Trau M, Graeser M, Harbeck N. Immunomodulatory gene networks predict treatment response and survival to de-escalated, anthracycline-free neoadjuvant chemotherapy in triple-negative breast cancer in the WSG-ADAPT-TN trial. Mol Cancer. 2025 Mar 26;24(1):96. doi: 10.1186/s12943-025-02275-0.

    PubMed 40140821

  • Richters L, Gluz O, Weber-Lassalle N, Christgen M, Haverkamp H, Kuemmel S, Kayali M, Kates RE, Grischke EM, Altmuller J, Forstbauer H, Thiele H, Braun M, Warm M, Ossowski A, Wuerstlein R, Ernst C, Graeser M, Linn SC, Nitz U, Hauke J, Kreipe HH, Schmutzler RK, Hahnen E, Harbeck N. Genetic Alterations, Therapy Response, and Survival Among Patients With Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461639. doi: 10.1001/jamanetworkopen.2024.61639.

    PubMed 40009381

  • Kolberg-Liedtke C, Feuerhake F, Garke M, Christgen M, Kates R, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Graeser M, Nitz U, Kreipe H, Gluz O, Harbeck N. Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial. Breast Cancer Res. 2022 Sep 2;24(1):58. doi: 10.1186/s13058-022-01552-w.

    PubMed 36056374

  • Gluz O, Nitz U, Kolberg-Liedtke C, Prat A, Christgen M, Kuemmel S, Mohammadian MP, Gebauer D, Kates R, Pare L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Graeser M, Pelz E, Jozwiak K, Zu Eulenburg C, Kreipe HH, Harbeck N; ADAPT TN investigators. De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial. Clin Cancer Res. 2022 Nov 14;28(22):4995-5003. doi: 10.1158/1078-0432.CCR-22-0482.

    PubMed 35797219

  • Graeser M, Schrading S, Gluz O, Strobel K, Herzog C, Umutlu L, Frydrychowicz A, Rjosk-Dendorfer D, Wurstlein R, Culemann R, Eulenburg C, Adams J, Nitzsche H, Prange A, Kummel S, Grischke EM, Forstbauer H, Braun M, Potenberg J, von Schumann R, Aktas B, Kolberg-Liedtke C, Harbeck N, Kuhl CK, Nitz U. Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials. Breast Cancer Res. 2021 Mar 18;23(1):36. doi: 10.1186/s13058-021-01413-y.

    PubMed 33736679

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-Paclitaxel, Gemcitabine and Carboplatin in people with Breast Cancer, run by Women's Cancer Study Group GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine (time frame: After 12 weeks of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815242, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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