Breast NeoplasmsPhase 3CAMELLIANCT01917279
Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
A Phase 3 study testing Docetaxel plus Capecitabine, Intermittent Capecitabine and Metronomic Capecitabine in people with Breast Neoplasms and Neoplasms by Site, run by Binghe Xu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Neoplasms by Site, Neoplasm Metastasis
- What is being tested?
- Docetaxel plus Capecitabine, Intermittent Capecitabine and Metronomic Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Prior hormone therapy for metastatic disease is allowed but must stop before study entry.
- KPS>70.
- Life expectancy of ≥12 weeks
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences
Beijing, 100021
Binghe Xu, MD, PhD, +86-10-87788826, xubinghe@medmail.com.cn
Fei Ma, MD, +86-13910217780, mafei2011@139.com
About this study
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
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).
- Being tested
- Docetaxel plus Capecitabine, Intermittent Capecitabine, Metronomic Capecitabine
- Keywords
- Metastatic Breast Cancer, Antineoplastic Agents, Therapeutic Uses, Antimetabolites, Tubulin Modulators, Maintenance chemotherapy, Metronomic chemotherapy, Capecitabine, Docetaxel
- Medical subject headings
- Breast Neoplasms, Neoplasms by Site, Neoplasm Metastasis, Breast Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 CapecitabineDrug
Also called Xeloda
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
Metronomic CapecitabineDrug
Also called Xeloda
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Capecitabine | Active comparator | Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle. Receives: Drug: Docetaxel plus Capecitabine; Drug: Intermittent Capecitabine |
| Metronomic Capecitabine | Experimental | Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle Receives: Drug: Docetaxel plus Capecitabine; Drug: Metronomic Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first).
Measured: up to 36 months
Secondary outcomes (6)
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.
Measured: up to 36 months
Overall survival (OS):
Time from randomization to death
Measured: up to 52 months
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.
Measured: up to 36 months
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
Measured: up to 36 months
Time to Progression (TTP)
Time from randomization to disease progression
Measured: up to 36 months
QoL
Using the EORTC quality of life questionnaire QLQ-C30
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binghe Xu
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor-investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, MD, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917279
- Sponsor's protocol ID
- ML28898
- Acronym
- CAMELLIA
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2013
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39648226Guan 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.
PubMed 30606259
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01917279
- Acronym / sponsor ID
- CAMELLIA / ML28898
- Keywords
- Metastatic Breast Cancer, Antineoplastic Agents, Therapeutic Uses, Antimetabolites, Tubulin Modulators, Maintenance chemotherapy, Metronomic chemotherapy, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Binghe Xu
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2013
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Capecitabine | Active comparator | Drug: Docetaxel plus Capecitabine, Drug: Intermittent CapecitabineCapecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle. |
| Metronomic Capecitabine | Experimental | Drug: Docetaxel plus Capecitabine, Drug: Metronomic CapecitabineCapecitabine 500 mg three times daily on days 1-21 of each 3-week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel plus CapecitabineEligible 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. | Drug | Intermittent Capecitabine, Metronomic Capecitabine |
| Intermittent CapecitabineAlso: XelodaCapecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle | Drug | Intermittent Capecitabine |
| Metronomic CapecitabineAlso: XelodaCapecitabine 500 mg three times daily on days 1-21 of each 3-week cycle | Drug | Metronomic Capecitabine |
Primary outcome
Progression Free Survival (PFS)
Time frame: up to 36 months
Time from randomization to progression or death (whichever occurred first).
6 secondary outcomes
Adverse events (AEs)
Time frame: up to 36 months
Overall survival (OS):
Time frame: up to 52 months
Overall Response rates (ORR)
Time frame: up to 36 months
Clinical Benefit rate (CBR)
Time frame: up to 36 months
Time to Progression (TTP)
Time frame: up to 36 months
QoL
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 39648226Yi 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.
- Derived from this study: PubMed 30606259Guan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binghe Xu, MD, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel plus Capecitabine, Intermittent Capecitabine and Metronomic Capecitabine in people with Breast Neoplasms and Neoplasms by Site, run by Binghe Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu, MD, PhD (+86-10-87788826, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.