Breast NeoplasmsPhase 3NCT02181101
Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial
A Phase 3 study testing FEC-DocGemzar adjuvant chemotherapy, FEC-Doc adjuvant chemotherapy and Zoledronic acid i.v. 2 years in people with Breast Neoplasms, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(Doc)-chemotherapy versus 3 cycles… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- FEC-DocGemzar adjuvant chemotherapy, FEC-Doc adjuvant chemotherapy and Zoledronic acid i.v. 2 years
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,754 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary epithelial invasive carcinoma of the breast pT1-4, pM0
- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk pN0/NX, defined as: 'pT ≥ 2 or histopathological grade 3 or age ≤ 35 or negative hormone receptor status'
- Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
- Females ≥ 18 years of age
- Performance Status ≤ 2 on Eastern Cooperative Oncology Group (ECOG) Scale
- Adequate bone marrow reserve: leucocytes ≥ 3.0 x 10^9/l and platelets ≥ 100 x 10^9/l
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- Bilirubin within one fold of the reference laboratory's normal range, aspartate aminotransferase (ASAT) (serum glutamate oxalacetate transaminase, SGOT), alanine aminotransferase (ALAT) (serum glutamate pyruvate transaminase, SGPT) and alkaline phosphatase (AP) within 1,5 fold of the reference laboratory's normal range for patients
- Intention of regular follow-up visits for the duration of the study
- Ability to understand the nature of the study and to give written informed consent
Who cannot join
- Inflammatory breast cancer
- Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
- History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism)
- Prior treatment with bisphosphonates within the last 6 months
- Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
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- Cardiomyopathy with impaired ventricular function (New York Heart Association Functional Classification Class (NYHA) > II), cardiac arrythmias influencing left ventricular ejection fraction (LVEF) and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
- Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol
- Use of any investigational agent within 3 weeks prior to inclusion
- Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)
- 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.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Universität München, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
Munich, Bavaria, 80337
About this study
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the disease free survival after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be required to have histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.
After surgery, leading to R0 resection of the invasive and intraductal components of the primary tumor, patients will be randomized to one of the following treatments:
Read more
First randomization
AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22
AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc), administered on day 1, repeated on day 22
Second randomization B
BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three years
BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years
During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid and 400 i.E. Vitamin D p.o. qid.
Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6 months after the completion of cytostatic treatment or with premenopausal hormone levels as defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will start after the end of chemotherapy.
All patients with breast conserving therapy or more than 3 axillary lymph node metastases or in the following cases after mastectomy:
- T3/T4-carcinoma
- T2-carcinoma > 3 cm
- multicentric tumor growth
- lymphangiosis carcinomatosa or vessel involvement
- involvement of the pectoralis fascia or a safety margin < 5 mm. will receive adjuvant radiotherapy.
- Conditions
- Breast Neoplasms
- Being tested
- FEC-DocGemzar adjuvant chemotherapy, FEC-Doc adjuvant chemotherapy, Zoledronic acid i.v. 2 years, Zoledronic acid i.v. 5 years
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEC-DocGemzar adjuvant chemotherapyDrug
FEC-Doc adjuvant chemotherapyDrug
Zoledronic acid i.v. 2 yearsDrug
Zoledronic acid i.v. 5 yearsDrug
| Study group | Role | What they receive |
|---|---|---|
| AA-BA | Experimental | FEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 5 years Receives: Drug: FEC-DocGemzar adjuvant chemotherapy; Drug: Zoledronic acid i.v. 5 years |
| AB-BA | Experimental | FEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 5 years Receives: Drug: FEC-Doc adjuvant chemotherapy; Drug: Zoledronic acid i.v. 5 years |
| AA-BB | Experimental | FEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 2 years Receives: Drug: FEC-DocGemzar adjuvant chemotherapy; Drug: Zoledronic acid i.v. 2 years |
| AB-BB | Active comparator | FEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 2 years Receives: Drug: FEC-Doc adjuvant chemotherapy; Drug: Zoledronic acid i.v. 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 5 years
Secondary outcomes (6)
Overall survival
Measured: 5 years
Number of adverse events related to cancer therapy observed
Measured: 5 years
Quality of life
Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQ-BR23 questionnaire
Measured: 5 years
Number of skeletal/bone-related adverse events observed including osteonecrosis of the jaw
Measured: 5 years
Number of patients who develop malignant disease other than recurrence of the breast cancer treated within the trial
Measured: 5 years
Distant disease free survival
Disease free survival excluding ipsilateral breast tumor recurrence, regional invasive recurrences, contralateral breast cancer, and all in situ carcinomas
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startSep 2005
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Chugai Pharma USA, Eli Lilly and Company, Novartis, Sanofi, Janssen Diagnostics, LLC
- Responsible party
- Principal investigator, Prof. Dr. med. Harald Leo Sommer, Ludwig-Maximilians - University of Munich
- Investigators
- Harald L Sommer, Prof. Dr. med., Study director, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181101
- Sponsor's protocol ID
- SUCCESS-A
- Other IDs
- 2005-000490-21, 2005
- Status last verified
- Jul 2014
- First submitted
- 4 Jun 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Friedl TWP, Fasching PA, Hartkopf AD, Tesch H, Lorenz R, Heinrich G, Blohmer JU, Fehm T, Mueller V, Schneeweiss A, Beckmann MW, Ruebner M, Harbeck N, Pantel K, Dustin D, Cai M, Rack B, Janni W. Clinical Relevance of Post-Treatment Circulating Tumor DNA Detection in Early Breast Cancer Using a Tissue-Free Epigenomic Assay: A 2-Year Landmark Analysis. JCO Precis Oncol. 2026 Sep;10(9):e2600095. doi: 10.1200/PO-26-00095. Epub 2026 Sep 4.
PubMed 42696691Friedl TWP, Fehm T, Muller V, Lichtenegger W, Blohmer J, Lorenz R, Forstbauer H, Fink V, Bekes I, Huober J, Juckstock J, Schneeweiss A, Tesch H, Mahner S, Brucker SY, Heinrich G, Haberle L, Fasching PA, Beckmann MW, Coleman RE, Janni W, Rack B. Prognosis of Patients With Early Breast Cancer Receiving 5 Years vs 2 Years of Adjuvant Bisphosphonate Treatment: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1149-1157. doi: 10.1001/jamaoncol.2021.1854.
PubMed 34165508de Gregorio A, Haberle L, Fasching PA, Muller 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. Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial. Breast Cancer Res. 2020 Oct 23;22(1):111. doi: 10.1186/s13058-020-01348-w.
PubMed 33097092Deniz 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, Haberle L, Beckmann MW, Schneeweiss A, Schrader I, Janni W, Rack B, Friedl TW. Differential prognostic relevance of patho-anatomical factors among different tumor-biological subsets of breast cancer: Results from the adjuvant SUCCESS A study. Breast. 2019 Apr;44:81-89. doi: 10.1016/j.breast.2018.12.008. Epub 2018 Dec 20.
PubMed 30690254Vilsmaier T, Rack B, Janni W, Jeschke U, Weissenbacher T; SUCCESS Study Group. Angiogenic cytokines and their influence on circulating tumour cells in sera of patients with the primary diagnosis of breast cancer before treatment. BMC Cancer. 2016 Jul 27;16:547. doi: 10.1186/s12885-016-2612-7.
PubMed 27464822Jueckstock J, Rack B, Friedl TW, Scholz C, Steidl J, Trapp E, Tesch H, Forstbauer H, Lorenz R, Rezai M, Haberle L, Alunni-Fabbroni M, Schneeweiss A, Beckmann MW, Lichtenegger W, Fasching PA, Pantel K, Janni W; SUCCESS Study Group. Detection of circulating tumor cells using manually performed immunocytochemistry (MICC) does not correlate with outcome in patients with early breast cancer - Results of the German SUCCESS-A- trial. BMC Cancer. 2016 Jul 7;16:401. doi: 10.1186/s12885-016-2454-3.
PubMed 27387743Widschwendter 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. The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial. Breast Cancer Res. 2015 Sep 18;17(1):129. doi: 10.1186/s13058-015-0639-3.
PubMed 26385214
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial
- ClinicalTrials.gov ID
- NCT02181101
- Acronym / sponsor ID
- SUCCESS-A
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,754 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- AstraZeneca, Chugai Pharma USA, Eli Lilly and Company, Novartis, Sanofi, Janssen Diagnostics, LLC
- Study start
- Sep 2005
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the disease free survival after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be required to have histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.
After surgery, leading to R0 resection of the invasive and intraductal components of the primary tumor, patients will be randomized to one of the following treatments:
First randomization
AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22
AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc), administered on day 1, repeated on day 22
Second randomization B
BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three years
BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years
During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid and 400 i.E. Vitamin D p.o. qid.
Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6 months after the completion of cytostatic treatment or with premenopausal hormone levels as defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will start after the end of chemotherapy.
All patients with breast conserving therapy or more than 3 axillary lymph node metastases or in the following cases after mastectomy:
- T3/T4-carcinoma
- T2-carcinoma > 3 cm
- multicentric tumor growth
- lymphangiosis carcinomatosa or vessel involvement
- involvement of the pectoralis fascia or a safety margin < 5 mm. will receive adjuvant radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AA-BA | Experimental | Drug: FEC-DocGemzar adjuvant chemotherapy, Drug: Zoledronic acid i.v. 5 yearsFEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 5 years |
| AB-BA | Experimental | Drug: FEC-Doc adjuvant chemotherapy, Drug: Zoledronic acid i.v. 5 yearsFEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 5 years |
| AA-BB | Experimental | Drug: FEC-DocGemzar adjuvant chemotherapy, Drug: Zoledronic acid i.v. 2 yearsFEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 2 years |
| AB-BB | Active comparator | Drug: FEC-Doc adjuvant chemotherapy, Drug: Zoledronic acid i.v. 2 yearsFEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary epithelial invasive carcinoma of the breast pT1-4, pM0
- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk pN0/NX, defined as: 'pT ≥ 2 or histopathological grade 3 or age ≤ 35 or negative hormone receptor status'
- Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
- Females ≥ 18 years of age
- Performance Status ≤ 2 on Eastern Cooperative Oncology Group (ECOG) Scale
Key exclusion criteria (12 listed)
- Inflammatory breast cancer
- Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
- History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism)
- Prior treatment with bisphosphonates within the last 6 months
- Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEC-DocGemzar adjuvant chemotherapy | Drug | AA-BA, AA-BB |
| FEC-Doc adjuvant chemotherapy | Drug | AB-BA, AB-BB |
| Zoledronic acid i.v. 2 years | Drug | AA-BB, AB-BB |
| Zoledronic acid i.v. 5 years | Drug | AA-BA, AB-BA |
Primary outcome
Disease free survival
Time frame: 5 years
6 secondary outcomes
Overall survival
Time frame: 5 years
Number of adverse events related to cancer therapy observed
Time frame: 5 years
Quality of life
Time frame: 5 years
Number of skeletal/bone-related adverse events observed including osteonecrosis of the jaw
Time frame: 5 years
Number of patients who develop malignant disease other than recurrence of the breast cancer treated within the trial
Time frame: 5 years
Distant disease free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Derived from this study: PubMed 42696691Friedl TWP, Fasching PA, Hartkopf AD, Tesch H, Lorenz R, Heinrich G, Blohmer JU, Fehm T, Mueller V, Schneeweiss A, Beckmann MW, Ruebner M, Harbeck N, Pantel K, Dustin D, Cai M, Rack B, Janni W. Clinical Relevance of Post-Treatment Circulating Tumor DNA Detection in Early Breast Cancer Using a Tissue-Free Epigenomic Assay: A 2-Year Landmark Analysis. JCO Precis Oncol. 2026 Sep;10(9):e2600095. doi: 10.1200/PO-26-00095. Epub 2026 Sep 4.
- Derived from this study: PubMed 34165508Friedl TWP, Fehm T, Muller V, Lichtenegger W, Blohmer J, Lorenz R, Forstbauer H, Fink V, Bekes I, Huober J, Juckstock J, Schneeweiss A, Tesch H, Mahner S, Brucker SY, Heinrich G, Haberle L, Fasching PA, Beckmann MW, Coleman RE, Janni W, Rack B. Prognosis of Patients With Early Breast Cancer Receiving 5 Years vs 2 Years of Adjuvant Bisphosphonate Treatment: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1149-1157. doi: 10.1001/jamaoncol.2021.1854.
- Derived from this study: PubMed 33097092de Gregorio A, Haberle L, Fasching PA, Muller 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. Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial. Breast Cancer Res. 2020 Oct 23;22(1):111. doi: 10.1186/s13058-020-01348-w.
- Derived from this study: PubMed 30690254Deniz 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, Haberle L, Beckmann MW, Schneeweiss A, Schrader I, Janni W, Rack B, Friedl TW. Differential prognostic relevance of patho-anatomical factors among different tumor-biological subsets of breast cancer: Results from the adjuvant SUCCESS A study. Breast. 2019 Apr;44:81-89. doi: 10.1016/j.breast.2018.12.008. Epub 2018 Dec 20.
- Derived from this study: PubMed 27464822Vilsmaier T, Rack B, Janni W, Jeschke U, Weissenbacher T; SUCCESS Study Group. Angiogenic cytokines and their influence on circulating tumour cells in sera of patients with the primary diagnosis of breast cancer before treatment. BMC Cancer. 2016 Jul 27;16:547. doi: 10.1186/s12885-016-2612-7.
- Derived from this study: PubMed 27387743Jueckstock J, Rack B, Friedl TW, Scholz C, Steidl J, Trapp E, Tesch H, Forstbauer H, Lorenz R, Rezai M, Haberle L, Alunni-Fabbroni M, Schneeweiss A, Beckmann MW, Lichtenegger W, Fasching PA, Pantel K, Janni W; SUCCESS Study Group. Detection of circulating tumor cells using manually performed immunocytochemistry (MICC) does not correlate with outcome in patients with early breast cancer - Results of the German SUCCESS-A- trial. BMC Cancer. 2016 Jul 7;16:401. doi: 10.1186/s12885-016-2454-3.
- Derived from this study: PubMed 26385214Widschwendter 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. The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial. Breast Cancer Res. 2015 Sep 18;17(1):129. doi: 10.1186/s13058-015-0639-3.
- Related InfoLink provided by the sponsor.
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald L Sommer, Prof. Dr. med. study director
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FEC-DocGemzar adjuvant chemotherapy, FEC-Doc adjuvant chemotherapy and Zoledronic acid i.v. 2 years in people with Breast Neoplasms, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181101, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.