NCT01917279

Brief Summary

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

6.8 years

First QC Date

July 19, 2013

Last Update Submit

July 21, 2020

Conditions

Breast NeoplasmsNeoplasms by SiteNeoplasm MetastasisBreast DiseasesSkin Diseases

Keywords

Metastatic Breast CancerAntineoplastic AgentsTherapeutic UsesAntimetabolitesTubulin ModulatorsMaintenance chemotherapyMetronomic chemotherapyCapecitabineDocetaxel

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    Time from randomization to progression or death (whichever occurred first).

    up to 36 months

Secondary Outcomes (6)

  • Adverse events (AEs)

    up to 36 months

  • Overall survival (OS):

    up to 52 months

  • Overall Response rates (ORR)

    up to 36 months

  • Clinical Benefit rate (CBR)

    up to 36 months

  • Time to Progression (TTP)

    up to 36 months

  • +1 more secondary outcomes

Study Arms (2)

Intermittent Capecitabine

ACTIVE COMPARATOR

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.

Drug: Docetaxel plus CapecitabineDrug: Intermittent Capecitabine

Metronomic Capecitabine

EXPERIMENTAL

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Drug: Docetaxel plus CapecitabineDrug: Metronomic Capecitabine

Interventions

Docetaxel plus CapecitabineDRUG

Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.

Intermittent CapecitabineMetronomic Capecitabine
Intermittent CapecitabineDRUG

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle

Also known as: Xeloda
Intermittent Capecitabine
Metronomic CapecitabineDRUG

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Also known as: Xeloda
Metronomic Capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent obtained prior to initiation of any study-specific procedures or treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
  • Female patients aged ≥ 18 years.
  • Histologically confirmed and documented HER2-negative metastatic breast cancer.
  • Previously untreated first-line chemotherapy.
  • Patients with at least one measurable lesion according to RECIST criteria at study entry.
  • Documented ER/PgR status.
  • Prior hormone therapy for metastatic disease is allowed but must stop before study entry.
  • KPS\>70.
  • Life expectancy of ≥12 weeks

You may not qualify if:

  • Previous chemotherapy for metastatic breast cancer.
  • Prior adjuvant/neoadjuvant chemotherapy within 6 months prior to first study treatment administration.
  • Prior (radical)radiotherapy for the treatment of metastatic disease or major surgical procedure within 28 days prior to the first study treatment,
  • Inadequate bone marrow function: absolute neutrophil count (ANC): \<1.5 x 109/L, platelet count\<75 x 109/L or hemoglobin \<100g/L.
  • Inadequate liver or renal function, defined as:
  • Serum (total) bilirubin \>2 x the upper limit of normal (ULN) for the institution
  • AST/SGOT or ALT/SGPT \>2.5 x ULN (\>5 x ULN in patients with liver metastases)
  • ALP \>2.5 x ULN at baseline (\>5 x ULN in patients with liver metastases).
  • Serum creatinine\>140umol/L.
  • Pregnant or lactating females.
  • Her-2 positive (ICH +++ or FISH positive).
  • Symptomatic cerebral parenchyma and/or leptomeningeal metastases.
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
  • Pre-existing peripheral neuropathy ≥grade 1 according NCI CTCAE 4.0.
  • Mental disease or other conditions affecting on the compliance of patients.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy Of Medical Sciences

Beijing, 100021, China

RECRUITING

Related Publications (2)

  • Yi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0.

    PMID: 39648226DERIVED

  • Guan X, Ma F, Li C, Wu S, Hu S, Huang J, Sun X, Wang J, Luo Y, Cai R, Fan Y, Li Q, Chen S, Zhang P, Li Q, Xu B. The prognostic and therapeutic implications of circulating tumor cell phenotype detection based on epithelial-mesenchymal transition markers in the first-line chemotherapy of HER2-negative metastatic breast cancer. Cancer Commun (Lond). 2019 Jan 3;39(1):1. doi: 10.1186/s40880-018-0346-4.

    PMID: 30606259DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms by SiteNeoplasm MetastasisBreast DiseasesSkin Diseases

Interventions

DocetaxelCapecitabine

Condition Hierarchy (Ancestors)

NeoplasmsSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Binghe Xu, MD, PhD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, MD, PhD

CONTACT

+86-10-87788826xubinghe@medmail.com.cn

Fei Ma, MD

CONTACT

+86-13910217780mafei2011@139.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Medical Department

Study Record Dates

First Submitted

July 19, 2013

First Posted

August 6, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

CN(1)