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| Sponsor: | Breast International Group |
|---|---|
| Collaborators: |
European Organization for Research and Treatment of Cancer NCIC Clinical Trials Group International Breast Cancer Study Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045032 |
Purpose
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating primary breast cancer in women who have completed adjuvant chemotherapy.
PURPOSE: This randomized phase III trial is studying two different regimens of trastuzumab and observation only to compare how well they work in treating women with breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | HERA: A Randomised Three-Arm Multi-Centre Comparison Of 1 Year And 2 Years Of Herceptin Versus No Herceptin In Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy |
| Study Start Date: | December 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nonmetastatic primary invasive adenocarcinoma of the breast
HER2-positive disease with one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| Argentina | |
| Hospital Aleman de Buenos Aires | |
| Buenos Aires, Argentina, 1118 | |
| Australia, Australian Capital Territory | |
| Saint John of God Hospital | |
| Geelong, Australian Capital Territory, Australia, 3220 | |
| Australia, Queensland | |
| Toowoomba Hospital | |
| Toowoomba, Queensland, Australia, 4350 | |
| Australia, Victoria | |
| Andrew Love Cancer Centre | |
| Geelong, Victoria, Australia, 3220 | |
| Australia, Western Australia | |
| Mount Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Austria | |
| A. oe. Krankenhaus Wiener Neustadt | |
| Wiener Neustadt, Austria, A-2700 | |
| LKH Villach | |
| Villach, Austria, 9500 | |
| Landeskrankenanstalten - Salzburg | |
| Salzburg, Austria, A-5020 | |
| Landeskrankenhaus Feldkirch | |
| Feldkirch-Tisis, Austria, 6807 | |
| Landeskrankenhaus Klagenfurt | |
| Klagenfurt, Austria, 9026 | |
| Landeskrankenhaus St. Poelten | |
| St. Poelten, Austria, 3100 | |
| Innsbruck Universitaetsklinik | |
| Innsbruck, Austria, A-6020 | |
| LKH Voecklabruck | |
| Voecklabruck, Austria, 4840 | |
| St. Vincent's Hospital | |
| Linz Donau, Austria, A-4010 | |
| Universitaetsklinik fuer Innere Medizin I | |
| Vienna, Austria, 1090 | |
| Wilhelminenspital der Stadt Wien | |
| Vienna, Austria, A-1160 | |
| Belgium | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Cazk Groeninghe - Campus St-Niklaas | |
| Kortrijk, Belgium, B-8500 | |
| Centre Hospitalier Notre Dame - Reine Fabiola | |
| Charleroi, Belgium, 6000 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Centre Hospitalier Universitaire de Tivoli | |
| La Louviere, Belgium, 7100 | |
| CHU Liege - Domaine Universitaire du Sart Tilman | |
| Liege, Belgium, B-4000 | |
| Clinique Sainte Elisabeth | |
| Namur, Belgium, 5000 | |
| Clinique Saint-Joseph | |
| Liege, Belgium, B 4000 | |
| Centre Hospitalier Peltzer-La Tourelle | |
| Verviers, Belgium, B-4800 | |
| Hospital Serruys Ziekenhuis | |
| Oostende, Belgium, 8400 | |
| Institut Jules Bordet | |
| Brussels, Belgium, B-1000 | |
| Reseau Hospitalier De Medecine Sociale | |
| Baudour, Belgium, 7331 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Brazil | |
| Faculdade De Medicina Do ABC | |
| Santo Andre, Brazil, 09060-650 | |
| Hospital Santa Rita | |
| Porto Alegre, Brazil, 91330-490 | |
| Hospital Sao Lucas da PUCRS | |
| Porto Alegre, Brazil, 90610-000 | |
| Instituto Nacional de Cancer | |
| Rio de Janeiro, Brazil, 20560-120 | |
| Brazil, Rio Grande do Sul | |
| Porto Alegre Hospital | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Fraser Valley Cancer Centre at British Columbia Cancer Agency | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| Algoma Regional Cancer Program at Sault Area Hospital | |
| Sault Sainte Marie, Ontario, Canada, P6A 2C4 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Windsor Regional Cancer Centre at Windsor Regional Hospital | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Royal Victoria Hospital of Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Trillium Health Centre - Mississauga Site | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Canada, Prince Edward Island | |
| Prince Edward Island Cancer Centre at Queen Elizabeth Hospital | |
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
| Canada, Quebec | |
| Hopital du Saint-Sacrement, Quebec | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Chile | |
| Hospital Dr. Sotero Del Rio | |
| Santiago, Chile | |
| Hospital Clinico San Borja Arriaran | |
| Santiago, Chile | |
| Fundacion Arturo Lopez Perez | |
| Santiago, Chile, 29 | |
| Hospital Militar | |
| Santiago, Chile | |
| Instituto Nacional Del Cancer | |
| Santiago, Chile | |
| China | |
| Queen Mary Hospital | |
| Hong Kong, China | |
| Tongji Medical University | |
| Wuhan, China, 430030 | |
| Tuen Mun Hospital | |
| Hong Kong, China | |
| Colombia | |
| Instituto Nacional De Cancerologia | |
| Bogota, Colombia | |
| Croatia | |
| Clinical Hospital Center Split | |
| Split, Croatia, 21000 | |
| Denmark | |
| Centralsygehus I Esbjerg | |
| Esbjerg, Denmark, 6700 | |
| Centralsygehuset I Naestved | |
| Naestved, Denmark, 4700 | |
| Herning Central Hospital | |
| Herning, Denmark, 7400 | |
| Hillerod Hospital | |
| Hillerod, Denmark, 3400 | |
| Sonderborg Sygehus | |
| Sonderborg, Denmark, 6400 | |
| France | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Hopital Clinique Claude Bernard | |
| Metz, France, 57072 | |
| Germany | |
| Charite - Campus Charite Mitte | |
| Berlin, Germany, D-10117 | |
| Dr. Horst-Schmidt-Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Evangelisches Bethesda Krankenhaus GmbH | |
| Essen, Germany, D-45355 | |
| Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt | |
| Rostock, Germany, D-18059 | |
| Frauenklinik Vom Roten Kreuz | |
| Munich, Germany, 80637 | |
| Henriettenstiftung Krankenhaus | |
| Hanover, Germany, D-30559 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Kreiskrankenhaus Leonberg - Frauenklinik | |
| Leonberg, Germany, D-71229 | |
| Universitaet Ulm | |
| Ulm, Germany, D-89075 | |
| St. Vincentius-Kliniken | |
| Karlsruhe, Germany, D-76137 | |
| Martin Luther Universitaet | |
| Halle, Germany, D-06097 | |
| Universitaets-Hautklinik Heidelberg | |
| Heidelberg, Germany, D-69115 | |
| Universitaetsklinikum Freiburg | |
| Freiburg, Germany, D-79106 | |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| University Hospital Schleswig-Holstein - Kiel Campus | |
| Kiel, Germany, D-24105 | |
| Greece | |
| Evaggelismos Hospital | |
| Athens, Greece, 10676 | |
| Greece, Crete | |
| University of Crete School of Medicine | |
| Heraklion, Crete, Greece, 71110 | |
| Guatemala | |
| Centro Medico | |
| Guatemala City, Guatemala, 01010 | |
| Hospital Roosevelt | |
| Guatemala City, Guatemala, 01010 | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, New Territories, Hong Kong | |
| Hungary | |
| Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia | |
| Budapest, Hungary, H-1032 | |
| National Institute of Oncology | |
| Budapest, Hungary, 1122 | |
| Semmelweis University | |
| Budapest, Hungary, 1082 | |
| Ireland | |
| Cork University Hospital | |
| Cork, Ireland | |
| Israel | |
| Sieff Hospital | |
| Safed, Israel, 13110 | |
| Italy | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Azienda Ospedaliera | |
| Reggio Emilia, Italy, 42100 | |
| Azienda Ospedaliero Careggi | |
| Florence, Italy, 50139 | |
| Carlo Poma Hospital | |
| Mantova, Italy, 46100 | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Istituto Clinico Humanitas | |
| Rozzano, Italy, 20089 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Morgagni-Pierantoni Ospedale | |
| Forli, Italy, 47100 | |
| Ospedale A. Manzoni | |
| Lecco, Italy, 23900 | |
| Ospedale B. Ramazzini | |
| Carpi, Italy, 41012 | |
| Ospedale Bellaria | |
| Bologna, Italy, I-40139 | |
| Ospedale Civile ASL 1 | |
| Sassari, Italy, 07100 | |
| Ospedale degli Infermi - ASL 12 | |
| Biella, Italy, 13900 | |
| Ospedale Niguarda Ca'Granda | |
| Milan, Italy, 20162 | |
| Ospedale Oncologico A. Businco | |
| Cagliari, Italy, 09100 | |
| Universita Degli Studi Di Florence | |
| Firenze (Florence), Italy, 50121 | |
| Ospedale Presenti Fenaroli | |
| Alzano-Lombardo, Italy, 24022 | |
| Ospedale San Filippo Neri | |
| Rome, Italy, 00135 | |
| Ospedale San Lazzaro | |
| Alba, Italy, 12051 | |
| Ospedale Sant' Eugenio | |
| Rome, Italy, 00144 | |
| Ospedale Santa Croce | |
| Cuneo, Italy, 12100 | |
| Ospedale Valduce | |
| Como, Italy, 22100 | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24100 | |
| Policlinico Monteluce | |
| Perugia, Italy, 06122 | |
| Presidio Ospedaliero | |
| Livorno, Italy, 57100 | |
| Primario U.O. di Oncologia Medica | |
| Trento, Italy, 38100 | |
| Spedali Civili di Brescia | |
| Brescia, Italy, 25124 | |
| Ospedale Ostetrico Ginecologica Sant Anna | |
| Turin, Italy, 10126 | |
| Universita di Torino | |
| Turin, Italy, 10126 | |
| University of Modena Hospital and Reggio Emilia School of Medicine | |
| Modena, Italy, 41100 | |
| Japan | |
| Tokai University School Of Medicine | |
| Kanagawa, Japan, 259-1193 | |
| Tokyo Metropolitan - Komagome Hospital | |
| Tokyo, Japan, 113-8677 | |
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| Yonsei Cancer Center at Yonsei University Medical Center | |
| Seoul, Korea, Republic of, 120-752 | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Diakonessenhuis Utrecht | |
| Utrecht, Netherlands, 3508 TG | |
| Maasland Hospital | |
| Sittard, Netherlands, 6131 BK | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Medical University | |
| Poznan, Poland, 61-878 | |
| Oncologic Center | |
| Gliwice, Poland, 44-101 | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3000 | |
| Hospital Distrital De Faro | |
| Faro, Portugal, 8000 | |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | |
| Lisbon, Portugal, 1099-023 Codex | |
| Instituto Portugues de Oncologia, Centro Regional de Coimbra | |
| Coimbra, Portugal, 3000-075 | |
| Maternidade Byssaia Barreto | |
| Coimbra, Portugal, 3000 | |
| University Hospital of Santa Maria | |
| Lisboa, Portugal, 1649-035 | |
| Russian Federation | |
| Moscow Oncology Hospital | |
| Moscow, Russian Federation, 107005 | |
| P.A. Hertzen Research Oncology Institute | |
| Moscow, Russian Federation, 125284 | |
| Singapore | |
| Johns Hopkins Singapore International Medical Centre | |
| Singapore, Singapore, 308433 | |
| South Africa | |
| Groote Schuur Hospital | |
| Cape Town, South Africa, 7925 | |
| Medical Oncology Centre of Rosebank | |
| Johannesburg, South Africa, 2193 | |
| Parklands Hospital | |
| Durban, South Africa, 4001 | |
| Pretoria - East Hospital | |
| Lynnwood, South Africa, 0081 | |
| Sandton Oncology Centre | |
| Johannesburg, South Africa, 2121 | |
| Spain | |
| Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro | |
| La Coruna, Spain, 15009 | |
| Complejo Hospitalario de Pontevedra | |
| Pontevedra, Spain, 36001 | |
| Complejo Hospitalario Santa Maria | |
| Orense, Spain, 32005 | |
| Complexo Hospitalario Xeral de Vigo | |
| Vigo Pontevedra, Spain, 36204 | |
| Consorci Hospitalari del Parc Tauli | |
| Sabadell, Spain, 08208 | |
| Hospital General Universitario De Guadalajara | |
| Guadalajara, Spain, 19002 | |
| Hospital de Gran Canaria Dr. Negrin | |
| Las Palmas de Gran Canaria, Spain, 35020 | |
| Hospital de la Princesa | |
| Madrid, Spain, 28006 | |
| Hospital De La Ribera | |
| Alzira, Spain, 46600 | |
| Hospital Del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Cuidad de Jaen | |
| Jaen, Spain, 23007 | |
| Hospital General Universitario Valencia | |
| Valencia, Spain, 41014 | |
| Hospital Insular de Gran Canaria | |
| Las Palmas, Spain, G.C. | |
| Hospital Juan Ramon Jimenez | |
| Huelva, Spain, 21005 | |
| Hospital Universidad Virgen Del Rocio | |
| Sevilla, Spain, E- 41013 | |
| Hospital Universitario Nuestra Senora de la Candelaria | |
| Santa Cruz de Tenerife, Spain, 38010 | |
| Hospital Universitario Miguel Servet | |
| Zaragoza, Spain, 59009 | |
| Hospital Universitario Canarias | |
| La Laguna, Spain, 38320 | |
| Hospital Universitario San Cecilio de Granada | |
| Granada, Spain, 18003 | |
| Hospital Virgen Del La Salud | |
| Toledo, Spain, 45004 | |
| Sweden | |
| Karolinska University Hospital - Huddinge | |
| Stockholm, Sweden, S-171 76 | |
| Sahlgrenska University Hospital - Molndal at Gothenburg University | |
| Molndal, Sweden, S-43180 | |
| Umea Universitet | |
| Umea, Sweden, SE-901 87 | |
| University Hospital of Linkoping | |
| Linkoping, Sweden, S-581 85 | |
| University Hospital of Malmoe | |
| Malmo, Sweden, 20502 | |
| Uppsala University Hospital | |
| Uppsala, Sweden, SE-75185 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Ospedale Beata Vergine | |
| Mendrisio, Switzerland, CH-6850 | |
| Spitaeler Chur AG | |
| Chur, Switzerland, CH-7000 | |
| UniversitaetsSpital Zuerich | |
| Zurich, Switzerland, CH-8091 | |
| Universitaetsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Thailand | |
| Chulalongkorn University Hospital | |
| Bangkok, Thailand, 10330 | |
| Ramathibodi Hospital | |
| Bangkok, Thailand, 10400 | |
| United Kingdom, England | |
| Airedale General Hospital | |
| West Yorkshire, England, United Kingdom, BD20 6TD | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Broomfield Hospital | |
| Chelmsford, Essex, England, United Kingdom, CM1 7ET | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Cookridge Hospital at Leeds Teaching Hospital NHS Trust | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Diana Princess of Wales Hospital | |
| Grimsby, England, United Kingdom, DN33 2BA | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Imperial College of Medicine | |
| London, England, United Kingdom, W12 0NN | |
| James Cook University Hospital | |
| Middlesbrough, England, United Kingdom, TS4 3BW | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Princess Royal Hospital | |
| Hull, England, United Kingdom, HU8 9HE | |
| Saint Margaret's Hospital | |
| Epping Essex, England, United Kingdom, CM16 6TN | |
| Bradford Hospitals NHS Trust | |
| Bradford, England, United Kingdom, BD9 6RJ | |
| Study Chair: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
| Study Chair: | Robert E. Coleman, MD, FRCP | Cancer Research Centre at Weston Park Hospital |
| Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
| Investigator: | Kathleen I. Pritchard, MD | Edmond Odette Cancer Centre at Sunnybrook |
| Study Chair: | Olivia Pagani, MD | Ospedale Beata Vergine |
More Information
| Study ID Numbers: | CDR0000256320, BIG-01-01, EU-20216, ROCHE-B016348E, ROCHE-B016348C, EORTC-10011, CAN-NCIC-MA24, IBCSG-28-02 |
| Study First Received: | September 6, 2002 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00045032 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Neoplasms Neoplasms by Site Immunologic Factors Skin Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Trastuzumab Adjuvants, Immunologic Breast Neoplasms Pharmacologic Actions Breast Diseases |