Skip to content
Triangle logo TriangleGet started
← Study library

NCT00593697 · CITED IN SOURCE DOCUMENTS

The Synergism Or Long Duration (SOLD) Study

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-03-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. 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. 2. Woman \> 18 years of age. 3. Histologically confirmed invasive breast cancer. 4. HER2-positive breast cancer (preferably assessed with CISH or FISH; if not available with immunohistochemistry 3+) 5. 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) Exclusion Criteria: 1. Presence of distant metastases. 2. Inflammatory breast cancer. 3. pT1bN0M0 (i.e. the longest tumor diameter 6 to 10 mm, node-negative) and histological grade 1. 4. 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. 5. Left ventricular ejection fraction less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography. 6. ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined. 7. Primary systemic cancer therapy (neoadjuvant chemotherapy or endocrine therapy) has been administered prior to breast surgery. 8. The WHO performance status \> 1. 9. Pregnant or lactating women. 10. 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. 11. More than 12 weeks between breast surgery and date of randomization. 12. Organ allografts with immunosuppressive therapy required. 13. Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. 14. Participation in any investigational drug study within 4 weeks preceding treatment start. 15. 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. 16. History of another malignancy within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix. 17. One or more of the following: * Blood hemoglobin \< 10.0 g/dL, neutrophils \< 1.5 x 109/L, platelet count \< 120 x 109/L * Serum/plasma creatinine \> 1.5 x Upper Limit of Normal (ULN) * Serum/plasma bilirubin \> ULN * Serum/plasma ALT and/or AST \> 1.5 x ULN * Serum/plasma alkaline phosphatase \> 2.5 x ULN 18. Serious uncontrolled infection or other serious uncontrolled concomitant disease. 19. Unwilling or unable to comply with the protocol for the duration of the study. 20. History of hypersensitivity to the investigational products or to drugs with similar chemical structures. 21. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by CTCAE version 3, unless related to mechanical etiology.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) (HT x3 -\> FE75C x3)
    intervention Names
    1. Drug: trastuzumab (9 weeks) + docetaxel
    label
    A
    type
    ACTIVE_COMPARATOR
  2. description
    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)
    intervention Names
    1. Drug: trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)
    label
    B
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. A
    description
    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)
    name
    trastuzumab (9 weeks) + docetaxel
    type
    DRUG
  2. arm Group Labels
    1. B
    description
    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)
    name
    trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2168
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Disease-free survival (DFS)
    time Frame
    3-10years
secondary Outcomes
  1. measure
    Overall survival, distant disease-free survival, cardiac event-free disease-free survival, left ventricle ejection fractions, adverse events, quality of life
    time Frame
    3-10years
Full study description
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.
Source references
references
  1. citation
    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
    type
    DERIVED
  2. citation
    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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-b54706e5bf7e80967c8e
      requested nct id
      NCT00593697
      primary nct id
      NCT00593697
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      payload sha256
      e91193037a46b5a9b928530ef0a6dd5047642494ad186a137d10585e72695307
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-b54706e5bf7e80967c8e
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00593697
      occurrences
      1. context exact
        000810017&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>]</li></ol></div></li><li>The <a href="/clinicaltrials/NCT00593697">SOLD</a> trial (NCT00593697) compared 9 weeks of trastuzumab with 1 year of trastuzumab in 2,174 women with HER2-positive breast cancer.[<a href="#cit/section
        end
        423221
        exact text
        NCT00593697
        start
        423210
      2. context exact
        rofessional&amp;language=English'); return(false);">Level of evidence A1</a>]</li></ol></div></li><li>The <a href="/clinicaltrials/NCT00593697">SOLD</a> trial (NCT00593697) compared 9 weeks of trastuzumab with 1 year of trastuzumab in 2,174 women with HER2-positive breast cancer.[<a href="#cit/section_6.138">138</a>]<div class="p
        end
        423250
        exact text
        NCT00593697
        start
        423239
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:35.419733+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice