Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy (NATAN)

March 4, 2015 updated by: German Breast Group

A Randomized, Multicenter, Open Phase III Study Comparing the Postoperative Use of Zoledronic Acid Versus no Treatment in Patients With Histological Tumor Residuals After Preoperative Anthracycline and Taxane Containing Chemotherapy for Primary Breast Cancer

The purpose of this study is to determine the event-free survival (EFS) after zoledronic acid for 5 years versus no postoperative treatment in patients with "chemo-insensitive" breast cancer (ypT1-4 and/or ypN1-3) after preoperative anthracycline/taxane containing chemotherapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is restricted to patients having had primary systemic chemotherapy for stage II and III breast cancer. Participation in a preoperative chemotherapy trial investigating anthracycline and taxane based regimen is allowed, but not mandatory for all patients. Patients must have significant remaining tumor tissue in the breast and/or axillary lymph node. This implies resistance to further chemotherapy and a clinically relevant risk for relapse. Bisphosphonates have a distinct mechanism of action and have demonstrated efficacy in the treatment of breast cancer with metastasis to the bone as well as adjuvant treatment after surgery of primary breast cancer. The 3rd generation bisphosphonate zoledronic acid has a favorable toxicity profile and can be conveniently given to patients over a long term period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
654

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, A-5020
        • LKH Salzburg, Uni.klinik f. Innere Med. III/Onkol. Amb.
    • Carinthia
      • St. Veit a. d. Glan, Carinthia, Austria, A-9300
        • A. ö. Krankenhaus der Barmherzigen Brüder, Interne Abteilung
      • Wolfsberg, Carinthia, Austria, A-9400
        • Landeskrankenhaus Wolfsberg, Chirurgische Abteilung
    • Lower Austria
      • Wien, Lower Austria, Austria
        • Medizinische Universitat Wien
    • Styria
      • Graz, Styria, Austria, A-8036
        • LKH-Univ. Klinikum Graz, Onkologie
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Universitäts Klinikum Innsbruck
    • Upper Austria
      • Linz, Upper Austria, Austria, A-4020
        • Allgemeines Krankenhaus der Stadt Linz, Innere Medizin 3/Zentrum f. Häm. u. Med. Onkologie
      • Steyr, Upper Austria, Austria, A-4400
        • Landeskrankenhaus Steyr, 2. Med. Abt. Onkologie
      • Wels, Upper Austria, Austria, A-4600
        • Klinikum Wels-Grieskirchen GmbH, Abt. f. Innere Medizin IV
    • Vorarlberg
      • Rankweil, Vorarlberg, Austria, 6830
        • Landeskrankenhaus Feldkirch
  • Germany
      • Berlin, Germany, 10367
        • Praxisklinik, Krebsheilkunde für Frauen / Brustzentrum
      • Berlin, Germany, 12559
        • DRK Kliniken Köpenick, Frauenklinik
      • Bremen, Germany, 28205
        • Onkologische Schwerpunktpraxis
      • Bremen, Germany, 28239
        • Evangelisches Diakonie-Krankenhaus, Frauenklinik
      • Friedrichshafen, Germany, 88045
        • Intern. Gemeinschaftspraxis
      • Hamburg, Germany, 22041
        • Facharzt für Frauenheilkunde und Geburtshilfe
      • Salzwedel, Germany, 29410
        • Krankenhaus Salzwedel
    • Baden-Württemberg
      • Aalen, Baden-Württemberg, Germany, 73430
        • Ostalb-Klinikum, ABC Brustzentrum, Frauenklinik
      • Böblingen, Baden-Württemberg, Germany, 71032
        • Klinikum Sindelfingen-Böblingen / Kliniken Böblingen, Frauenklinik
      • Karlsruhe, Baden-Württemberg, Germany, 76135
        • St. Vincentius Kliniken Karlsruhe
      • Lörrach, Baden-Württemberg, Germany, 79539
        • Onkol. Schwerpunktpraxis Dr. Knoblich
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Universitätsklinikum Mannheim, Frauenklinik
      • Pforzheim, Baden-Württemberg, Germany, 75179
        • Krankenhaus Siloah, Gynäkologie und Geburtshilfe
      • Reutlingen, Baden-Württemberg, Germany, 72764
        • Klinikum am Steinenberg
      • Rheinfelden, Baden-Württemberg, Germany, 79618
        • Frauenklinik Rheinfelden
      • Stuttgart, Baden-Württemberg, Germany, 70374
        • Krankenhaus Bad Cannstatt, Frauenklinik
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitätsklinikum Tübingen, Frauenklinik
    • Bayern
      • Ebersberg, Bayern, Germany, 85560
        • Kreiskrankenhaus Ebersberg, Gynäkologisch-onkologische Abteilung
      • Erlangen, Bayern, Germany, 91054
        • Universitätsklinikum Erlangen, Frauenklinik mit Poliklinik
      • Regensburg, Bayern, Germany, 93053
        • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe
      • Rosenheim, Bayern, Germany, 83022
        • Klinikum Rosenheim, Abt. Gynäkologie u. Geburtshilfe
    • Berlin
      • Berlin-Tempelhof, Berlin, Germany, 12107
        • Schwerpunktpraxis Gynäkologie, Onkologie, Naturheilverfahren
    • Brandenburg
      • Bernau, Brandenburg, Germany, 16321
        • Praxis Dr. Gottschalk, Fachärztin für Frauenheilkunde und Geburtshilfe
      • Fuerstenwalde, Brandenburg, Germany, 15517
        • Schwerpunktpraxis der Gynäkologie und Onkologie
      • Neuruppin, Brandenburg, Germany, 16816
        • Ruppiner Kliniken, Frauenklinik
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
        • Onkologie Bethanien, Onkologie / Tagesklinik
      • Frankfurt, Hessen, Germany, 60431
        • St. Markus Krankenhaus, Frauenklinik
      • Frankfurt/Höchst, Hessen, Germany, 65929
        • Städt. Kliniken Frankfurt-Höchst, Frauenklinik
      • Hanau, Hessen, Germany, 63450
        • Klinikum Stadt Hanau
      • Kassel, Hessen, Germany, 34125
        • Klinikum Kassel GmbH, Gynäkologische Ambulanz
      • Langen, Hessen, Germany, 63225
        • Asklepios Klinik, Frauenklinik
      • Lich, Hessen, Germany, 35423
        • Asklepios-Klinik Lich, Frauenklinik
      • Limburg, Hessen, Germany, 65549
        • St. Vincenz Krankenhaus, Frauenklinik
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinikum, Frauenklinik / Mutter-Kind-Zentrum
      • Neu-Isenburg, Hessen, Germany, 63263
        • GBG Forschungs GmbH
      • Wiesbaden, Hessen, Germany, 65189
        • St. Josefs-Hospital, Gynäkologie und Geburtshilfe
      • Wiesbaden, Hessen, Germany, 65197
        • Asklepios Paulinen Klinik, Frauenklinik
      • Wiesbaden, Hessen, Germany, 65199
        • Dr.-Horst-Schmidt-Kliniken GmbH, Klinik f. Gyn. und gyn. Onkologie
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17487
        • Universität Greifswald, Klinik für Frauenheilkunde und Geburtshilfe
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17039
        • Dietrich-Bonhoeffer Klinikum, Frauenklinik
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Klinikum Südstadt, Universitätsfrauenklinik
    • Niedersachsen
      • Celle, Niedersachsen, Germany, 29223
        • Allgm. Krankenhaus Celle, Frauenklinik
      • Cuxhaven, Niedersachsen, Germany, 27474
        • Krankenhaus Cuxhaven, Frauenklinik
      • Gifhorn, Niedersachsen, Germany, 38518
        • Kreiskrankenhaus Gifhorn, Interdisziplinäres Brustzentrum
      • Goslar, Niedersachsen, Germany, 38642
        • Onkologische Schwerpunktpraxis Dr. Tessen
      • Hameln, Niedersachsen, Germany, 31785
        • Kreiskrankenhaus Hameln, Brustzentrum
      • Hannover, Niedersachsen, Germany, 30559
        • Henriettenstiftung
      • Hannover, Niedersachsen, Germany, 30559
        • Vinzenzkrankenhaus, Gynäkologie
      • Hildesheim, Niedersachsen, Germany, 31134
        • Gemeinschaftspraxis Gynäkologie
      • Ilsede, Niedersachsen, Germany, 31241
        • Facharzt für Frauenheilkunde und Geburtshilfe
      • Stadhagen, Niedersachsen, Germany, 31655
        • Klinikum Schaumburg, Kreiskrankenhaus Stadthagen, Gynäkologie und Geburtshilfe
    • Niedersachsen.
      • Lüneburg, Niedersachsen., Germany, 21339
        • Schwerpunktpraxis, Internistisch-gynäkolog.-onkolog.
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
        • Onkologische Schwerpunktpraxis, Dres. Schäfer / Just / Görner
      • Bochum, Nordrhein-Westfalen, Germany, 44787
        • Praxis für Innere Medizin, Hämatologie, internistische Onkologie
      • Coesfeld, Nordrhein-Westfalen, Germany, 48653
        • Onkologische Schwerpunktpraxis Dr. Glados, Hämatologie / Internistische Onkologie
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40235
        • Luisenkrankenhaus, Senologie, Brustzentrum
      • Erkelenz, Nordrhein-Westfalen, Germany, 41812
        • Hermann-Josef Krankenhaus, Frauenklinik
      • Eschweiler, Nordrhein-Westfalen, Germany, 52249
        • St. Antonius Hospital, Klinik für Hämatologie u. Onkologie
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Universitätsklinikum Essen, Klinik für Frauenheilkunde und Geburtshilfe
      • Essen, Nordrhein-Westfalen, Germany, 45130
        • Gynäkologische Praxis Dr. Deertz
      • Essen, Nordrhein-Westfalen, Germany, 45131
        • Alfried-Krupp-Krankenhaus, Frauenklinik
      • Essen, Nordrhein-Westfalen, Germany, 45329
        • Marienhospital Altenessen
      • Herne, Nordrhein-Westfalen, Germany, 44625
        • Marienhospital Herne, Onkologische / Hämatologische Ambulanz
      • Ibbenbüren, Nordrhein-Westfalen, Germany, 49477
        • Elisabeth-Hospital, Frauenklinik
      • Köln, Nordrhein-Westfalen, Germany, 50924
        • Klinikum der Universität zu Köln, Klinik und Poliklinik für Gyn. und Geburtshilfe
      • Köln, Nordrhein-Westfalen, Germany, 50924
        • Klinikum der Universität zu Köln
      • Köln, Nordrhein-Westfalen, Germany, 50935
        • St. Elisabeth-KKH, Brustzentrum Koeln-Hohenlind
      • Witten, Nordrhein-Westfalen, Germany, 58452
        • Marienhospital Witten, Brustzentrum
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • St. Vincenz und Elisabeth-Hospital
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Uniklinikum, Klinik für Geburtshilfe und Gynäkologie
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • Krankenhaus Neunkirchen gGmbH, Frauenklinik
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • Klinikum Chemnitz gGmbH, Frauenklinik
      • Dresden, Sachsen, Germany, 01307
        • Technische Universität Dresden
      • Dresden, Sachsen, Germany, 01127
        • Gemeinschaftspraxis, Fachärzte für Innere Medizin, Hämatologie und Internistische Onkologie
    • Sachsen-Anhalt
      • Halle / Saale, Sachsen-Anhalt, Germany, 06110
        • Krankenhaus St. Elisabeth und St. Barbara Halle, Klinik für Gynäkologie und Geburtshilfe
      • Magdeburg, Sachsen-Anhalt, Germany, 39108
        • Klinikum der Otto-v.-Guericke-Universität, Frauenklinik
      • Quedlinburg, Sachsen-Anhalt, Germany, 06484
        • Klinikum Quedlinburg, Frauenklinik
      • Stendal, Sachsen-Anhalt, Germany, 39576
        • Johanniter-Krankenhaus Genthin-Stendal GmbH, Frauenheilkunde und Geburtshilfe
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • Ostholstein Kliniken GmbH Klinik Oldenburg, Zentrum für Gynäkologie und Geburtshilfe Sana Kliniken Ostholstein
    • Thüringen
      • Gera, Thüringen, Germany, 07548
        • SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen
      • Jena, Thüringen, Germany, 07743
        • Universitätsklinikum, Klinik für Frauenheilkunde und Geburtshilfe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
  • Complete baseline documentation sent to GBG;
  • Prior preoperative chemotherapy for at least 4 cycles, of which at least two must contain a taxane and an anthracycline;
  • Completely resected unilateral or bilateral primary carcinoma of the breast with histologically detectable tumor residuals (ypT1-4) and/or histology confirmed involvement of axillary nodes (ypN1-3). Sentinel node biopsy is allowed, but complete axillary clearance is mandatory in node positive cases;
  • A maximum interval of 3 years from date of axillary surgery to entering this trial;
  • Age 18 years or older;
  • Karnofsky index >= 70%;
  • Life expectancy of at least 10 years, disregarding the diagnosis of cancer;
  • No clinical evidence of local recurrence or distant metastases. Complete staging work-up: All patients must have breast ultrasound, chest X-ray, ultrasound or CT scan of the liver within 3 months prior to registration, as well as (bilateral) mammography or breast MRI and bone scan within 8 months prior to registration. In case of a positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated;
  • Adequate renal and hepatic function (serum creatinine, bilirubin, and transaminases within 1.5 × upper normal range);
  • Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

  • Known hypersensitivity reaction to the investigational compound;
  • Prior postoperative chemotherapy;
  • Prior treatment with bisphosphonates since breast cancer surgery;
  • Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures (barrier methods, intra uterine contraceptive devices, sterilization) during study treatment;
  • History of diseases with influence on bone metabolism, such as Paget's disease of bone and primary hyperparathyroidism or osteoporosis requiring treatment at the time of study entry or considered likely to become necessary within the six months
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
  • Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
  • Concurrent treatment with other experimental drugs or any other anti-cancer therapy;
  • Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute;
  • Serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or > 12.0 mg/dl (3.00 mmol/L)
  • Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry;
  • 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, 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)
  • Male patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment
Patients receive zoledronic acid (4mg) for 5 years. Additionally patients receive standard endocrine, radiologic and trastuzumab treatment, respectively
Drug: Zoledronic acid
Infusion of zoledronic acid (4 mg) every 4 weeks for six doses, followed by every 3 months for 8 doses, followed by every 6 months for 5 doses
Other Names:
  • Zometa
No Intervention: Observation
Patients will be under observation and receive standard endocrine, radiologic and trastuzumab treatment, respectively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The event-free survival (EFS) after zoledronic acid for 5 years versus no postoperative treatment in patients with "chemo-insensitive" breast cancer (ypT1-4 and/or ypN1-3) after preoperative anthracycline/taxane containing chemotherapy.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The overall survival in both treatment arms.
Time Frame: 5 years
5 years
The EFS with respect to the interval between surgery and randomization.
Time Frame: 5 years
5 years
The bone-metastasis free-survival in both arms.
Time Frame: 5 years
5 years
The toxicity of and compliance to zoledronic acid.
Time Frame: 5 years
5 years
The predictive value of primary breast tumor response on the effect of postoperative treatment.
Time Frame: 5 years
5 years
The prognostic impact of chemotherapy induced amenorrhea in premenopausal patients.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Breast Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis Pharmaceuticals
Austrian Breast & Colorectal Cancer Study Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gunter von Minckwitz, Prof. MD, GBG Forschungs GmbH, Hessen, Germany
  • Study Chair: Peter Dubsky, MD, Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GBG 36
  • NATAN
  • ABCSG 29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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