Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy

NCT02449993 | Completed

• 1 other identifier: MammaTyper_1.neo-adjuvant st.
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper™. According to the determined values for the individual parameters at least 4 subtypes can be distinguished to date

• Luminal A-type
• Luminal B-type
• HER2-type
• Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with Immunohistochemical methods will be evaluated. As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall survival (OS) will be reevaluated according to the new subtyping.

Conditions

Breast Cancer

Keywords

diagnostic study; analysis of estrogen receptor; progesterone receptor; Human epidermal growth factor receptor 2; Ki-67

Outcome Measures

Primary Outcomes (1)

• Agreement of new subtyping assessed as rate of patients in MammaTyper-subtype groups compared to rate of patients in subtype groups according to immunohistochemical analysis according to St. Gallen Guideline 2013

  For each MammaTyper and immunohistochemical based subtype categorization, percent agreement, positive and negative percent agreement as well as kappa-statistics are calculated.

  Baseline

Secondary Outcomes (3)

• Assess difference of 5 year OS of breast cancer subgroup Luminal A vs. combined subgroup (Luminal B (HER2 positive / HER2 negative), HER2 positive, triple negative), based on subtyping with MammaTyper™

  5 years from the date of patient registration

• Estimation of difference in prediction of pathologic complete remission for MammaTyperTM Ki-67 vs. local Ki-67 visual scoring assessment for Luminal tumors, whereby a positive difference is expected

  Baseline

• ESR1 mRNA is predictive for 5 year OS with low expression of ESR1 mRNA being associated with adverse outcome (rate of patients with 5 year OS and high or low expression of ESR1 mRNA)

  5 years from the date of patient registration

Study Arms (1)

MammaTyper™

MammaTyper™ will be used to assess tumor material of patients treated with neo-adjuvant therapy.

Device: MammaTyper™

Interventions

MammaTyper™ DEVICE

MammaTyper™ is an in vitro molecular diagnostic test for the quantitative detection of the biomarkers estrogen receptor (ESR1), progesterone receptor ( PgR), Human epidermal growth factor receptor 2 (HER2) and proliferation antigen Ki-67 on the basis of the values of the messenger ribonucleic acid (mRNA).

MammaTyper™

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

See Eligibility Criteria

You may qualify if:

• Women aged 18-70 years with histologically confirmed primary invasive breast cancer stages T2-T4/N0-N2/M0 with a tumor size of ≥ 2 cm as measured by ultrasound
• The patient provides a written informed consent for analysis of tumor material

You may not qualify if:

• Prior anticancer therapy with an anthracycline or other prior antitumor therapy for breast cancer
• Inflammatory or exulcerating breast cancer
• A second primary malignancy \[except carcinoma in situ (CIS) of the cervix or adequately treated nonmelanoma skin cancer\] unless diagnosed and treated ≥ 5 years ago with no evidence of recurrence
• Any serious concomitant systemic disorder

Sponsors & Collaborators

• BioNTech Diagnostics GmbH: lead

MeSH Terms

Conditions

Breast Neoplasms; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 21, 2015
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01