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Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC (CAMELLIA)

Primary Purpose

Breast Neoplasms, Neoplasms by Site, Neoplasm Metastasis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel plus Capecitabine

Intermittent Capecitabine

Metronomic Capecitabine

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Metastatic Breast Cancer, Antineoplastic Agents, Therapeutic Uses, Antimetabolites, Tubulin Modulators, Maintenance chemotherapy, Metronomic chemotherapy, Capecitabine, Docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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:
1. Serum (total) bilirubin >2 x the upper limit of normal (ULN) for the institution
2. AST/SGOT or ALT/SGPT >2.5 x ULN (>5 x ULN in patients with liver metastases)
3. ALP >2.5 x ULN at baseline (>5 x ULN in patients with liver metastases).
4. 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.
Other serious disease or medical condition:
1. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent.
2. Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias.
3. Uncontrolled acute infection
Inability to take or absorption oral medications.
Concurrent or within 30 days using drugs of other clinical trials.
Previous treatments containing Capecitabine (whether adjuvant or palliative treatment).
Previous treatments containing docetaxel within 12 months.
Known hypersensitivity to any of the study treatments or excipients.
Any other conditions the research consider not appropriate to take part in the trial.

Sites / Locations

Cancer Institute and Hospital, Chinese Academy Of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intermittent Capecitabine

Metronomic Capecitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

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

Secondary Outcome Measures

Adverse events (AEs)

Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested. Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine.

Overall survival (OS):

Time from randomization to death

Overall Response rates (ORR)

Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.

Clinical Benefit rate (CBR)

Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase

Time to Progression (TTP)

Time from randomization to disease progression

QoL

Using the EORTC quality of life questionnaire QLQ-C30

Full Information

NCT ID

NCT01917279

First Posted

July 19, 2013

Last Updated

July 21, 2020

Sponsor

Binghe Xu

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01917279

Brief Title

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

Acronym

CAMELLIA

Official Title

A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Binghe Xu

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms, Neoplasms by Site, Neoplasm Metastasis, Breast Diseases, Skin Diseases

Keywords

Metastatic Breast Cancer, Antineoplastic Agents, Therapeutic Uses, Antimetabolites, Tubulin Modulators, Maintenance chemotherapy, Metronomic chemotherapy, Capecitabine, Docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intermittent Capecitabine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Metronomic Capecitabine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel plus Capecitabine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intermittent Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metronomic Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Adverse events (AEs)

Description

Time Frame

up to 36 months

Title

Overall survival (OS):

Description

Time from randomization to death

Time Frame

up to 52 months

Title

Overall Response rates (ORR)

Description

Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.

Time Frame

up to 36 months

Title

Clinical Benefit rate (CBR)

Description

Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase

Time Frame

up to 36 months

Title

Time to Progression (TTP)

Description

Time from randomization to disease progression

Time Frame

up to 36 months

Title

QoL

Description

Using the EORTC quality of life questionnaire QLQ-C30

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Other serious disease or medical condition: History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent. Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias. Uncontrolled acute infection Inability to take or absorption oral medications. Concurrent or within 30 days using drugs of other clinical trials. Previous treatments containing Capecitabine (whether adjuvant or palliative treatment). Previous treatments containing docetaxel within 12 months. Known hypersensitivity to any of the study treatments or excipients. Any other conditions the research consider not appropriate to take part in the trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Binghe Xu, MD, PhD

Phone

+86-10-87788826

xubinghe@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Ma, MD

Phone

+86-13910217780

mafei2011@139.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, PhD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Institute and Hospital, Chinese Academy Of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, PhD

Phone

+86-10-87788826

xubinghe@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Fei Ma, MD

Phone

+86-13910217780

mafei2011@139.com

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Fei Ma, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

30606259

Citation

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.

Results Reference

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Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

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