NordicTrip a Translational Study of Preoperative Chemotherapy in TNBC

  • STATUS
    Recruiting
  • End date
    Dec 25, 2032
  • participants needed
    820
  • sponsor
    Lund University Hospital
Updated on 26 January 2021
paclitaxel
cyclophosphamide
growth factor
progesterone
carboplatin
capecitabine
immunohistochemistry
HER2
adenocarcinoma
progesterone receptor
erbb2
epidermal growth factor
breast adenocarcinoma
BRCA1
BRCA2
epirubicin
adenocarcinoma of the breast

Summary

Primary aim: Pathological complete response rate after preoperative chemotherapy is the primary end-point of the study, which will be evaluated by comparing the effects of neoadjuvant administration of a carboplatin-based treatment and treatment adding capecitabine on Pathological Complete Response (pCR).

Description

Primary aim: Pathological complete response rate after preoperative chemotherapy is the primary end-point of the study, which will be evaluated by comparing the effects of neoadjuvant administration of a carboplatin-based treatment and treatment adding capecitabine on pCR.

Primary translational aim: To investigate if the effects of the treatments depend on homologous repair deficiency (HRD)-status. More specifically, the aim is to test for differential effect of the two treatments on pCR for HRD-negative (HRD low and intermediate by oncoscan) and HRD-positive (HRD high by oncoscan) patients.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Breast Cancer Diagnosis, Brain Function, Triple Negative Breast Neoplasms, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, breast carcinoma, cancer, breast
Treatment epirubicin, cyclophosphamide, paclitaxel, carboplatin, epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin
Clinical Study IdentifierNCT04335669
SponsorLund University Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

patients older than 18 ages
any gender
distal radius fracture type A or B of AO classification managed with closed reduction and percutaneous pinning
and Informed Consent signature

Exclusion Criteria

associated ipsilateral fractures in the upper extremity
fractures attended and fixed at another institution
support external fixation
previous skin conditions (infection, ulcers)
limitation of wrist mobility prior to injury
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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