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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

StatusActive, Not Recruiting
PhasePhase 3
Started2014-02-27
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
Study Identification, Study Status, Study Description, Outcome Measures, Contacts/Locations v38
Primary endpoint(s) modified3 to 2 entries
WasPathologic complete response rate-(pCR rate), Rate of endocrine resistant disease-(First Phase), Recurrence-free survival (RFS)-(Second Phase)
NowRate of endocrine resistant disease-(First Phase), Recurrence-free survival (RFS)-(Second Phase)
Secondary endpoints+44 characters
Pathologic complete response rate-(pCR rate)
Study description+237 characters
[...] dministered for 24 weeks as neoadjuvant endocrine treatment decreasesincreases the proportion of endocrine resistantsensitive tumors* relative to patients treated with anastrozole. To determine [...] ministered for 24 weeks as neoadjuvant endocrine treatment, decreasesincreases the proportion of endocrine resistantsensitive tumors* relative to patients treated with anastrozole. If both of the fulvestrant containing arms are found to have an endocrine sensitive disease rate at least 10% higher than that of the anastrozole arm, we will assess whether the endocrine sensitive disease rate is greater with [...] [...]
Study sitesdetails revised at 2 of 860 sites
2026-01-20
Study Identification, Study Status, Contacts/Locations, IPDSharing v37
Primary completion date2025-08-31→2027-04-01
Completion date2025-08-31→2027-04-01
Study sitesdetails revised at 2 of 860 sites
Study titlerevised
Fulvestrant Andand/or Anastrozole in Treating Postmenopausal Patients withWith Stage II-III Breast Cancer Undergoing Surgery
2025-01-09
Study Identification, Study Status, Contacts/Locations, IPDSharing v36
Completion datenot stated→2025-08-31
Start date2013-12-13→2014-02-27
Study sitesdetails revised at 2 of 860 sites
Study titlerevised
Fulvestrant andAnd/or Anastrozole in Treating Postmenopausal Patients Withwith Stage II-III Breast Cancer Undergoing Surgery
2023-08-30
3 amendments v33-v35
3 re-verifications since 2021-07-19, no change to tracked fields
2020-06-12
Study Status v32
Primary completion date2025-08→2025-08-31
Show 31 earlier versions
2019-10-02
Study Status v31
Primary completion date2020-04→2025-08
2019-08-02
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Start date2013-12→2013-12-13
Enrollment targetestimated 1455→confirmed 1473
Study sitesdetails revised at 860 of 860 sites
2019-06-04
Study Status, Contacts/Locations v29
Study sites853→860
2019-02-19
Study Status, Contacts/Locations v28
Study sites848→853
2019-01-22
Study Status, Contacts/Locations v27
Study sites841→848
2018-12-04
Study Status, Contacts/Locations v26
Study sites849→841
2018-09-05
Study Status, Contacts/Locations v25
Study sites844→849
2018-07-16
Study Status, Contacts/Locations v24
Study sites802→844
2018-06-08
Study Status, Contacts/Locations v23
Study sites797→802
2018-05-04
Study Status, Contacts/Locations v22
Study sites793→797
2018-04-06
Study Status, Contacts/Locations v21
Study sites793 entries, revised
CharlotteGood HungerfordSamaritan HospitalMedical Center for Smilow Cancer Hospital-Torrington Care Family Cancer Center-Southhaven Baptist Cancer Institute-Starkville Central Care Cancer Center -Carrie JBolivar Saint BabbVincent Frontier Cancer Center BethMount IsraelSinai MedicalUnion CenterSquare SaintMount Luke'sSinai Roosevelt Hospital Center - Saint Luke's DivisionWest Park Ridge Hospital Breast Health Center
2018-03-06
Study Status, Contacts/Locations v20
Study sites784→793
2018-02-05
Study Status, Contacts/Locations v19
Study sites781→784
2018-01-12
Study Status, Contacts/Locations v18
Study sites768→781
2017-09-29
Study Status, Contacts/Locations v17
Study sites764→768
2017-08-15
Study Status, Contacts/Locations v16
Study sites763→764
2017-06-20
Study Status, Contacts/Locations v15
Study sites760→763
2017-05-24
Study Status, Contacts/Locations v14
Study sites758→760
2017-05-17
Study Status, Study Design v13
Enrollment target2820→1455
2017-04-19
Study Status, Contacts/Locations v12
Study sites753→758
2017-03-06
Study Status, Contacts/Locations v11
Study sites702→753
2017-01-24
Study Status, Contacts/Locations v10
Study sites686→702
2016-11-16
Study Status, Contacts/Locations v9
Study sites515→686
2016-09-15
Suspended→Recruiting Study Status, Contacts/Locations v8
Trial statusSuspended→Recruiting
Study sitesdetails revised at 515 of 515 sites
2016-08-31
Recruiting→Suspended Study Status, Contacts/Locations v7
Trial statusRecruiting→Suspended
Study sites509→515
2016-06-10
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2016-04→2020-04
Study sites475→509
Eligibility criteria-39 characters
[...] ete excision of the tumor in the breast and the lymph node. ThePrimary extenttumor ofmust disease is a solitary lesion where the lesion isbe: palpable its size can be measured bidimensional by tape, ruler or caliper technique and its largest tumor diameterdiameters is at least 2.0 cm (thatby isphysical consideredexamination measurableor by theradiological WHO criteria)assessment Note: Patients with contralateral ductal carcinoma in situ [...] d/or invasive breast cancer are not eligible. Patients with multifocal/multi-lesionalcentric breast cancer are(defined not eligible ifas more than one lesion i [...] [...]
Primary endpoints3 entries, revised
Pathologic complete response rate-(pCR rate) Rate of endocrine resistant disease-(Neo-adjuvantFirst Phase) Recurrence-free survival (RFS)-(Post surgerySecond Phase)
Study description-369 characters
PatientsThis willclinical betrial randomizedwas designed to oneexamine the pathologic outcomes of threepatients whose neoadjuvant treatment groups:course anastrozole,is fulvestrantdetermined orusing thean combinationearly marker of anastrozole and fulvestrant. Each cycle is 28 days for a total of 6 cycles. Surgery must be performed between days 15-28 of Cycle 6 in each treatment arm. Patients who are determined to have an endocrine resistantresistance tumor(namely, atKi67 weekafter 4 or week 12 willweeks discontinueof endocrine protocolneoadjuvant therapy. It) isas recommendedwell thatas asses [...] [...]
2015-09-09
Study Status, Contacts/Locations v5
Study sitescontacts updated at 2 of 475 sites
2015-06-19
Study Status, Outcome Measures, Eligibility, Contacts/Locations v4
Study sites138→475
Eligibility criteria+260 characters
[...] score of 6, 7 or 8 by local institution standard protocol. If an Allred Score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible. If ER positivity is < 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred Score to determine eligibility. Invasive breast cancer is Human Epidermal Growth Factor Rece [...] ior to registration: Absolute Neutrophil Count (ANC) > 1000/mm3mm^3 Platelet Count > 100,000/mm3mm^3 Total Bilirubin < 1.5 x upper limits of normal (ULN) Creati [...]
2014-03-05
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2013-11→2013-12
Study sites0→138
Secondary endpoints-46 characters
Pathologic complete response rate - (pCR rate)
Primary endpoints2 to 3 entries
Pathologic complete response rate - (pCR rate)
Study description-42 characters
[...] It is recommended that patients be switched to neoadjuvant paclitaxel or another taxane and/or anthracycline or CMFtreatment. After completion of surgery, those with a modified preoper [...] gned endocrine treatment for 4.5 years and those with a non-zero PEPI score will receive adjuvant chemotherapy +/- endocrine [...]
2013-11-12
Study Status v2
Re-verified, no change to tracked fields
2013-10-08
Study Status, Arms and Interventions, Eligibility v1
Eligibility criteria+7 characters
[...] defined as 0 or 1+ by immunohistochemistry (IHC) or with a fluorescence in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) < 2 if IHC 2+ by local [...] tration. Laboratory values ≤ 14 days prior to registration: GranulocytesAbsolute Neutrophil Count (ANC) > 1000/µlmm3 PlateletsPlatelet Count > 100,000/µlmm3 Total Bilirubin < 1.5 x upper limits of normal (ULN) Creatinine < 1.5 x ULN Serum alanine transaminase (ALT) < 2.5 x upper limits of normalULN Tissue acquisition: Patient must agree to provide the requi [...] re between 0-5 or HER2 positive by IHC (3+) or amplified by fluorescence in situ [...] [...]
2013-09-25
Original filing
The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.
Trial Details
NCT Number NCT01953588
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Recurrent Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer +1 more
Enrollment 1,473 participants
Start Date 2014-02-27
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-05