The Synergism Or Long Duration (SOLD) Study

NCT00593697 | Completed Phase 3 DMC

• 2 other identifiers: Protocol number FBCSG-01-2007EudraCT number 2007-002016-26
• Study Type: interventional
• Target: 2,168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare disease-free survival (DFS) of women treated with concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the same regimen followed by single-agent trastuzumab to complete one year of trastuzumab administration as adjuvant treatments of early HER2-positive breast cancer.

Conditions

Breast Neoplasms

Keywords

breast cancer; adjuvant therapy; trastuzumab; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  3-10years

Secondary Outcomes (1)

• Overall survival, distant disease-free survival, cardiac event-free disease-free survival, left ventricle ejection fractions, adverse events, quality of life

  3-10years

Study Arms (2)

A

ACTIVE COMPARATOR

Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) (HT x3 -\> FE75C x3)

Drug: trastuzumab (9 weeks) + docetaxel

B

ACTIVE COMPARATOR

Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) -\> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 -\>FE75C x3 -\> H3wkly x14)

Drug: trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)

Interventions

trastuzumab (9 weeks) + docetaxel DRUG

Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio: A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) (HT x3 -\>FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) -\> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 -\>FE75C x3 -\> H3wkly x14)

A

trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks) DRUG

Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) -\> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 -\>FE75C x3 -\> H3wkly x14)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has provided a written informed consent prior to study-specific screening procedures, with the understanding that she has the right to withdraw from the study at any time, without prejudice.
• Woman \> 18 years of age.
• Histologically confirmed invasive breast cancer.
• HER2-positive breast cancer (preferably assessed with CISH or FISH; if not available with immunohistochemistry 3+)
• A high risk of breast cancer recurrence with one of the following:
• Pathological N0 with the longest invasive tumor diameter \>5 mm
• Histologically confirmed regional node positive disease (pN+; nodal isolated tumor cells/cell clusters \< 0.2 mm in diameter (ITP) are not counted as a metastasis)

You may not qualify if:

• Presence of distant metastases.
• Inflammatory breast cancer.
• pT1bN0M0 (i.e. the longest tumor diameter 6 to 10 mm, node-negative) and histological grade 1.
• Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
• Left ventricular ejection fraction less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
• ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
• Primary systemic cancer therapy (neoadjuvant chemotherapy or endocrine therapy) has been administered prior to breast surgery.
• The WHO performance status \> 1.
• Pregnant or lactating women.
• Women of childbearing potential unless using a reliable and appropriate contraceptive method. Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age \< 55, must have a negative pregnancy test at baseline.
• More than 12 weeks between breast surgery and date of randomization.
• Organ allografts with immunosuppressive therapy required.
• Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
• Participation in any investigational drug study within 4 weeks preceding treatment start.
• Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding study participation.

Sponsors & Collaborators

• Finnish Breast Cancer Group: lead

Study Sites (1)

Helsinki University Central Hospital, Department of Oncology

Helsinki, 00029 HUS, Finland

Location

Related Publications (2)

• Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, Villman KK, Halonen P, Granstam-Bjorneklett H, Tanner M, Sailas L, Turpeenniemi-Hujanen T, Yachnin J, Huttunen T, Neven P, Canney P, Harvey VJ, Kellokumpu-Lehtinen PL, Lindman H. Long-Term Outcomes of Adjuvant Trastuzumab for 9 Weeks or 1 Year for ERBB2-Positive Breast Cancer: A Secondary Analysis of the SOLD Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429772. doi: 10.1001/jamanetworkopen.2024.29772.

  PMID: 39186271 DERIVED

• Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, Nyandoto P, Villman KK, Halonen P, Granstam-Bjorneklett H, Lundgren L, Sailas L, Turpeenniemi-Hujanen T, Tanner M, Yachnin J, Ritchie D, Johansson O, Huttunen T, Neven P, Canney P, Harvey VJ, Kellokumpu-Lehtinen PL, Lindman H. Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The SOLD Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1199-1206. doi: 10.1001/jamaoncol.2018.1380.

  PMID: 29852043 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel; CEF regimen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

FI (1)