Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Extended Bisphosphonate and Surveillance-Trial SUCCESS-Trial - SUCCESS

Conditions

This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the time to recurrence after randomisation in patients with early primary breast cancer.

de Gregorio A, Häberle L, Fasching PA, Müller V, Schrader I, Lorenz R, Forstbauer H, Friedl TWP, Bauer E, de Gregorio N, Deniz M, Fink V, Bekes I, Andergassen U, Schneeweiss A, Tesch H, Mahner S, Brucker SY, Blohmer JU, Fehm TN, Heinrich G, Lato K, Beckmann MW, Rack B, Janni W.

2020-10-2317 citations

10.1186/s13058-020-01348-w

Differential prognostic relevance of patho-anatomical factors among different tumor-biological subsets of breast cancer: Results from the adjuvant SUCCESS A study.

Deniz M, DeGregorio A, DeGregorio N, Bekes I, Widschwendter P, Schochter F, Ernst K, Scholz C, Bauer EC, Aivazova-Fuchs V, Weissenbacher T, Kost B, Jueckstock J, Andergassen U, Steidl J, Trapp E, Fasching PA, Häberle L, Beckmann MW, Schneeweiss A, Schrader I, Janni W, Rack B, Friedl TW.

2018-12-208 citations

10.1016/j.breast.2018.12.008

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial.

Widschwendter P, Friedl TW, Schwentner L, DeGregorio N, Jaeger B, Schramm A, Bekes I, Deniz M, Lato K, Weissenbacher T, Kost B, Andergassen U, Jueckstock J, Neugebauer J, Trapp E, Fasching PA, Beckmann MW, Schneeweiss A, Schrader I, Rack B, Janni W, Scholz C.

2015-09-1877 citations

10.1186/s13058-015-0639-3

Interventions

Product Name: Taxotere Pharmaceutical Form: Powder for infusion INN or Proposed INN: Docetaxel CAS Number: 114977-28-5 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients may be included in the study only if they meet all the following criteria: 1. Primary epithelial invasive carcinoma of the breast pT1-4, pM0 2. Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>2 or histopathological grade 3, or age 18 years of age 5. Performance Status 3.0 x 109/l and platelets >100 x 109/l 8. Bilirubin within one fold of the reference laboratory’s normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1.5 fold of the reference laboratory’s normal range for patients 9. Intention of regular follow up visits for the duration of the study 10. Ability to understand the nature of the study and to give written informed consentconsent 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

Exclusion criteria: 1. Inflammatory breast cancer 2. Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study 3. History of treatment or disease affecting bone metabolism (e.g., Paget’s disease, primary hyperparathyroidism) 4. Prior treatment with bisphosphonates within the last 6 months 5. Severe renal insufficiency as evidenced by creatinine clearance II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication 8. Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol 9. Use of any investigational agent within 3 weeks prior to inclusion 10. Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured) 11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 12. Recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objectives of this study are to compare the following items in the four regimen arms: · Overall survival time after randomization · Distant disease free survival · Toxicity · Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQ-BR23 questionnaire · Skeletal related events · Incidence of secondary primaries · Endpoints of adjunct translational research program Additional Scientific Objectives: The predictive and prognostic value of MRD surveillance as defined in the relevant section of the SUCCESS-protocol. The predictive and prognostic value of additional surveillance markers as defined in the relevant section of the SUCCESS-protocol.;Primary end point(s): The primary objective of this study is to compare the time to recurrence after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy,and to compare the time to recurrence after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate.;Main Objective: The primary objective of this study is to compare the time to recurrence after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy,and to compare the time to recurrence after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate.	—

Measure

Time frame

Secondary Objective: The secondary objectives of this study are to compare the following items in the four regimen arms: · Overall survival time after randomization · Distant disease free survival · Toxicity · Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQ-BR23 questionnaire · Skeletal related events · Incidence of secondary primaries · Endpoints of adjunct translational research program Additional Scientific Objectives: The predictive and prognostic value of MRD surveillance as defined in the relevant section of the SUCCESS-protocol. The predictive and prognostic value of additional surveillance markers as defined in the relevant section of the SUCCESS-protocol.;Primary end point(s): The primary objective of this study is to compare the time to recurrence after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy,and to compare the time to recurrence after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate.;Main Objective: The primary objective of this study is to compare the time to recurrence after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamid(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)-chemotherapy,and to compare the time to recurrence after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate.

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Countries

Germany

Outcome results

None listed