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JOURNAL ONKOLOGIE – STUDIE
Subito

Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

Rekrutierend

NCT-Nummer:
NCT02810743

Studienbeginn:
Januar 2017

Letztes Update:
22.01.2021

Wirkstoff:
ddAC-CP-Olaparib, ddAC-mini CTC

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
The Netherlands Cancer Institute

Collaborator:
-

Studienleiter

Sabine Linn, Prof. MD
Principal Investigator
NKI-AvL

Kontakt

Studienlocations
(3 von 11)

Antoni van Leeuwenhoek
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Sabine C Linn, MD
Phone: +3120512
Phone (ext.): 2951
E-Mail: s.linn@nki.nl

Vincent de Jong, MD
E-Mail: subito@nki.nl
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant

phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer

patients) comparing optimized standard-dose chemotherapy with intensified, alkylating

chemotherapy with stem cell rescue.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Women and men with stage III adenocarcinoma of the breast harboring signs of a breast

cancer with features of homologous recombination deficiency (HRD)

- Age of 18-65 years

- The tumor must be HER2-negative

- Treatment must start within 8 weeks after the last surgical resection

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

- Previous radiation therapy

- Previous chemotherapy

- Any previous treatment with a PARP-inhibitor, including olaparib

- Pre-existing neuropathy from any cause in excess of Grade 1

- Chronic concomitant use of known strong or moderate CYP3A inducers

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - assessed up to 120 months):
time from randomization to death from any cause.



Secondary outcome:

1. Recurrence free interval (Time Frame - assessed up to 120 months):
time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first

2. Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03 (Time Frame - up to 30 days after end of treatment):
Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

3. cost-effectiveness measured by costs per quality-adjusted life years (QALYs) (Time Frame - assessed up to 120 months):
cost-effectiveness measured by costs per quality-adjusted life years (QALYs)

4. Patient reported outcomes (Time Frame - assessed up to 24 months):
Patient reported outcomes; including quality of life (QoL) determined by a comprehensive panel of QoL questionnaires

5. cost-effectiveness measured by incremental cost-effectiveness ratio (ICER) (Time Frame - assessed up to 120 months):
cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)

Studien-Arme

  • Active Comparator: ddAC-CP-Olaparib
    ddAC; doxorubicin 60 mg/m² as an i.v. bolus and cyclophosphamide 600 mg/m² as an i.v. bolus on day 1 every 2 weeks ddAC must be supported with prophylactic pegfilgrastim 6 mg s.c. given 24-48 hours after completion of administration of EVERY chemotherapy cycle CP; carboplatin/paclitaxel (CP) consisting of carboplatin (AUC 6) on day 1 and paclitaxel (80 mg/m2) on day 1,8 and 15 of a 21 days cycle. In total 4 courses of CP will be administered. Olaparib will be administered in Dutch centers only, as monotherapy for one year at a dose of 300 mg BID, starting 3 weeks after adjuvant radiotherapy, or, if radiotherapy is not indicated, 3-5 weeks after the last CP cycle. Patients without a (near) pCR will receive adjuvant capecitabine at a starting dose of 1000-1250 mg/m2, twice a day, on days 1-14 every 3 weeks for eight cycles.
  • Active Comparator: ddAC-mini CTC
    ddAC; doxorubicin 60 mg/m² as an i.v. bolus and cyclophosphamide 600 mg/m² as an i.v. bolus on day 1 every 2 weeks ddAC must be supported with prophylactic pegfilgrastim 6 mg s.c. given 24-48 hours after completion of administration of EVERY chemotherapy cycle intensified alkylating 'mini' CTC (2x) cyclophosphamide 3000 mg/m2 day 1 mesna 500 mg (push) + 2000 mg in 24 hours day 1 carboplatin (400 mg/m2; (or AUC=5 in patients with a calculated creatinine-clearance of <100 ml/min)) days 1,2 thiotepa 250 mg/m2 day 2 Patients without a (near) pCR will receive adjuvant capecitabine at a starting dose of 1000-1250 mg/m2, twice a day, on days 1-14 every 3 weeks for eight cycles.

Geprüfte Regime

  • ddAC-CP-Olaparib:
    ddAC-CP-Olaparib
  • ddAC-mini CTC:
    ddAC - mini CTC

Quelle: ClinicalTrials.gov


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