Multicenter, randomized, double-blind, placebo-controlled parallel group study to demonstrate the efficacy (quality of life) and safety of the standardized mistletoe extract PS76A2 during chemotherapy and follow-up in patients with breast cancer

• Conditions: Female patients with breast cancer shortly after surgery [pTNM classification: pT1-T4, pN0-N+ (0-9 positive lymph nodes), pM0] qualified for adjuvant chemotherapy according to FEC scheme as standard of care; MedDRA version: 13.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-000841-36-PL
• Lead Sponsor: Rottapharm Madaus, Madaus GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-18
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

1) Female patient
2) Postsurgical condition of breast cancer with TNM classification
- pT1mic, pT1a, 1b, 1c, 2, 3 or 4
- pN0, pN+ with a maximum of 9 positive axillar lymph nodes
- pM0
3) Patient is eligible for adjuvant chemotherapy according to the following scheme as standard of care: FEC (minimum three to maximum six 3-week cycles)
4) Pre- or postmenopausal state
5) Age between 18 and 60 years (18 and 70 years included).
6) School education > 7 years
7) Oral and written informed consent to participate in the study according to ICH-GCP and applicable national law
8) Women of childbearing potential must use at least one highly effective method of birth control during the whole study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Inability to answer the quality of life scales.
2) Two-sided location of breast cancer at study enrolment.
3) Carcinoma in situ.
4) Concomitant malignancy at study enrolment.
5) Administration of prohibited concomitant medication at study enrolment. Note: The use of prohibited drugs during the study will induce the exclusion from the per protocol population.
6) Radiation therapy prior to or at study enrolment in a total dose of > 60 Gy. Note:The administration of radiation therapy during the study period is allowed as long as the total dose does not exceed 60 Gy.
7) Deviation from the planned course of screening period:
- Interval between surgery and first day of chemotherapy (= Day 1; = S2) greater than 70 days
- Interval between surgery and first day of chemotherapy less than 15 days
- Interval between S0 and first day of chemotherapy less than 14 days
- Screening Visit S1 outside Day –7 (± 1 day)
- Screening Visit S2 outside Day 1

8) Known hypersensitivity to protein or mistletoe preparations
9) Chronic progressive infections (e.g. tuberculosis).
10) Auto-immune diseases
11) Alcohol abuse (> 50 g ethanol per day).
12) Nicotine abuse (> 20 cigarettes per day).
13) Pregnancy or breast feeding.
14) Participating in another clinical trial within 30 days before study enrolment, or concurrent participating in another clinical trial.
15) Other circumstances that make the investigator expect an incomplete study participation of the patient (e.g. planned removal).
16) Cancellation of informed consent to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate the influence of PS76A2 on quality of life in patients with breast cancer receiving adjuvant chemotherapy quantified by FACT-G questionnaire.;Secondary Objective: Secondary objectives are to investigate the effect of PS76A2 on QoL quantified by GLQ-8, Spitzer's uniscale, FACT-B (i.e. FACT-G including additional concerns for patients with breast cancer), and EORTC QLQ-C30 as well as the effect of PS76A2 on the course of chemotherapy, on the hematological profile, and on safety variables.;Primary end point(s): The aim of the primary statistical analysis is to prove the superiority of PS76A2 ('active') to 'placebo' in patients with breast cancer receiving adjuvant chemotherapy with regard to QoL measurements by means of FACT-G. The primary endpoint is a cumulated change variable based on differences versus baseline (S1, S2, S3) after 4 (3-week) chemotherapy cycles.