SWOG clinical trial number
S0307

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Closed
Phase
III
Accrual
100%
Abbreviated Title
ADJUVANT: Bisphosphonates as Adjuvant Therapy for Breast Cancer
Activated
11/15/2005
Closed
02/01/2010
Participants
NCORP, Members, Medical Oncologists, Surgeons, Pathologists, CTSU, Affiliates

Research committees

Breast Cancer

Treatment

Clodronate Zoledronic Acid Ibandronate

Eligibility Criteria Expand/Collapse

--Must be female;
--Histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) w/ no evidence of metastatic disease;
--Must receive standard (systemic)adjuvant therapy for their breast cancer;
--Chemotherapy, hormone therapy, or combined chemo/hormone therapy is permitted. Additional therapies are allowed including radiation therapy and biologic agents (e.g. Herceptin, Avastin, hematopoietic growth factors);
--Patients who receive biologic agents only or RT only (w/o chemotherapy and/or hormone therapy) are not eligible;
--Patients who are at such a low risk of recurrence that adjuvant therapy will not be prescribed are not eligible;
--Neoadjuvant therapy is permitted, but enrollment must occur after completion of surgery;
--May enroll prior to, simultaneously with, or after beginning adjuvant systemic therapy; patients receiving hormonal therapy alone (no chemo) or preoperative chemotherapy should be enrolled within 84 days (12 weeks) after the date of final surgical procedure;
--Patients receiving adjuvant post-operative chemotherapy may be enrolled up to 8 weeks after completion of chemotherapy;
--Additional biological therapy or RT is allowed at any time before or after registration;
--Patients who wish to submit tissue and serum for banking must consent to the procedures for collection;
--Must have a PS = 0-2;
--Must not be co-enrolled on protocols that have bone density as an endpoint;
--May be registered to any other locoregional or systemic therapy breast cancer study, including cooperative group studies, as long as the protocol does not specifically exclude co-enrollment;
--Previous bisphosphonate use for bone density OK, as long as the bisphosphonate is discontinued at the time of registration (no other forms of bisphosphonates, other than those prescribed in this study, may be used or planned during protocol treatment);
--Dental examination w/in 6 months prior to registration;
--Patients w/ skeletal pain are eligible if bone scan and/or roentgenological examination fails to disclose metastatic disease;
--Patients must not have a history of esophageal stricture of motility disorders;
--Patients w/ a history of gastroesophageal reflux disorder (GERD) are eligible, but caution should be used when administering oral bisphosphonates;
--Patients must not be pregnant or nursing, and must agree to use an effective contraceptive method while on this trial if of reproductive potential; women of child-bearing potential must have a pregnancy test performed within 72 hrs prior to initiation of treatment;
--No other malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

--Labs: serum creatinine <= 2X IULN and a calculated creatinine clearance of >= 30 ml/min w/in 7 days prior to registration, w/ no renal failure;

Publication Information Expand/Collapse

2020

Phase III Randomized Trial of Bisphosphonates as Adjuvant Therapy in Breast Cancer: S0307

JR Gralow;W Barlow;A Paterson;J Miao;D Lew;A Stopeck;D Hayes;D Hershman;M Schubert;M Clemons;C Van Poznak;E Dees;J Ingle;CI Falkson;A Elias;M Messino;J Margolis;S Dakhil;H Chew;K Dammann;J Abrams;R Livingston;G Hortobagyi Journal of the National Cancer Institute Jul 1;112(7):698-707; Oct 31[Online ahead of print]

PMid: PMID31693129 | PMC number: PMC7357327

Healthcare utilization and cost of care in elderly breast cancer patients enrolled in SWOG clinical trials

D Hershman;C Till;J Wright;M Accordino;R Vaidya;W Barlow;S Ramsey;J Unger Breast Cancer Research and Treatment Jun;181(2):455-463

PMid: PMID32306168

2019

Factors associated with osteonecrosis of the jaw in women with breast cancer receiving highdose bisphosphonates to prevent breast cancer metastases as part of the SWOG 0307 trial

D Kizub;J Miao;M Schubert;A Paterson;M Clemons;E Dees;J Ingle;CI Falkson;W Barlow;G Hortobagyi;J Gralow J Clin Oncol 37, 2019 (suppl; abstr 552); ASCO Annual Meeting (May 31-June 4, 2019, Chicago, IL), poster session

Fractures in women with breast cancer receiving high-dose bisphosphonates to prevent breast cancer metastases as part of the SWOG S0307 trial (ClinicalTrials.gov Identifier: NCT00127205)

R Yung;J Miao;AHG Paterson;M Clemons;E Dees;JN Ingle;CI Falkson;W Barlow;G Hortobagyi;J Gralow San Antonio Breast Cancer Symposium (Dec 10-14, 2019, San Antonio, TX), P2-18-03, poster

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Association of Cardiovascular Risk Factors With Cardiac Events and Survival Outcomes Among Patients With Breast Cancer Enrolled in SWOG Clinical Trials

D Hershman;C Till;S Shen;J Wright;S Ramsey;W Barlow;J Unger Journal of Clinical Oncology Sep 10;36(26):2710-2717

PMid: PMID29584550 | PMC number: PMC6127026

Statin use, site of recurrence, and survival among post-menopausal women taking bisphosphonates as adjuvant therapy for primary breast cancer (SWOG S0307)

D Kizub;J Miao;A Stopeck;P Thompson;A Paterson;M Clemons;E Dees;J Ingle;CI Falkson;W Barlow;G Hortobagyi;JR Gralow San Antonio Breast Cancer Symposium (Dec 4-8, 2018, San Antonio, TX), poster, P1-17-03

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

History of diabetes and outcome among participants 65 or older in SWOG clinical trials

DL Hershman;C Till;JD Wright;S Ramsey;W Barlow;J Unger JCO Clinical Cancer Informatics Nov;1:1-12; DOI: https://doi.org/10.1200/CCI.17.00040 Publishedonlineonascopubs.org/journal/ccion November 20, 2017.

PMid: PMID30657402

Association Between Cardiovascular Risk Factors and Cardiac Events Among Breast Cancer Patients Enrolled in SWOG Clinical Trials

D Hershman;C Till;J Wright;S Ramsey;W Barlow;JM Unger San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster

2015

Phase III trial of bisphosphonates as adjuvant therapy in primary breast cancer: SWOG/Alliance/ECOG-ACRIN/NCIC Clinical Trials Group/NRG Oncology study S0307(NCT00127205)

J Gralow;W Barlow;A Paterson;D Lew;A Stopeck;D Hayes;D Hershman;M Schubert;M Clemons;C Van Poznak;EC Dees;JN Ingle;C Falkson;A Elias;M Messino;J Margolis;S Dakhil;H Chew;R Livingston;G Hortobagyi Journal of Clinical Oncology 33:5s, 2015 (suppl; abstr 503);American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), oral presentation;

2014

SWOG S0307 phase III trial of bisphosphonates as adjuvant therapy in primary breast cancer: Comparison of toxicities and patient-stated preference for oral versus intravenous delivery (ClinicalTrials.gov Identifier: NCT00127205)

JR Gralow;WE Barlow;A Paterson;D Lew;A Stopeck;DF Hayes;DL Hershman;M Schubert;M Clemons;CH Van Poznak;BE Dees;JN Ingle;C Falkson;AD Elias;M Messino;JH Margolis;S Dakhil;H Chew;R Livingston;G Hortobagyi Journal of Clinical Oncology 32:5s (suppl; abstr 558); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), general poster session;

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Research Committee(s)
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Activated
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Open
Phase