NCT00448266

Randomized Phase II/III Study of Intensified Alkylating Agent Chemotherapy With Peripheral Blood Progenitor Cell Support in the Preoperative Chemotherapy of Breast Tumors That Are Deficient for Homologous Recombination.

Terminated Phase 2/Phase 3 Last updated 20 January 2021

What this trial tests

Phase 2/Phase 3 trial testing Intensified Cyclophophamide, Carboplatin and Thiotepa in Breast Cancer in 12 participants. Terminated before completion.

Timeline

1 May 2007

Primary endpoint
1 February 2010

1 February 2011

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 May 2007
Primary completion	1 February 2010
Estimated completion	1 February 2011
Sites	1 location across Netherlands

Drugs / interventions tested

• Intensified Cyclophophamide, Carboplatin and Thiotepa — full drug profile →
• dose dense adriamycine and cyclophosphamide — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

The Netherlands Cancer Institute

Who can join

Adults 18 to 59, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of tumors with HRD (phase II part)
• pCR rate

Sponsor's own description

This phase II/III trial will investigate the ability of chemotherapy with 'Intensified Aklylating Agents (IAA) to achieve a high pathological complete response (pCR) rate when employed in the preoperative chemotherapy of breast cancer with evidence of a Homologous Recomination Deficiency (HRD).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mammary tumor-derived CCL2 enhances pro-metastatic systemic inflammation through upregulation of IL1β in tumor-associated macrophages.
   Kersten K, Coffelt SB, Hoogstraat M, Verstegen NJM, et al · · 2017 · cited 89× · PMID 28919995 · DOI 10.1080/2162402x.2017.1334744
2. Next generation sequencing of triple negative breast cancer to find predictors for chemotherapy response.
   Lips EH, Michaut M, Hoogstraat M, Mulder L, et al · · 2015 · cited 58× · PMID 26433948 · DOI 10.1186/s13058-015-0642-8
3. Comprehensive characterization of pre- and post-treatment samples of breast cancer reveal potential mechanisms of chemotherapy resistance.
   Hoogstraat M, Lips EH, Mayayo-Peralta I, Mulder L, et al · · 2022 · cited 30× · PMID 35523804 · DOI 10.1038/s41523-022-00428-8