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

Breast Cancer Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01815242
• Other study ID #: WSG-AM06 / ADAPT TN
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: West German Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: October 2024
• Est. primary completion date: March 2015
• 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

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)

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• nab-Paclitaxel

• Gemcitabine

• Carboplatin

Locations

Country	Name	City	State
Germany	Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany	Moenchengladbach

Sponsors (2)

Lead Sponsor	Collaborator
West German Study Group	Celgene

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
Primary	Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine	pCR will be measured after 12 weeks of randomized treatment.	After 12 weeks of therapy
Primary	Comparison: pCR in responders vs. non-responders	pCR will be measured after 12 weeks of randomized treatment.	After 12 weeks of therapy