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Metastatic Breast CancerPhase 3NCT04263298

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

A Phase 3 study testing Fulvestrant and Capecitabine Oral Product in people with Metastatic Breast Cancer, run by Herui Yao at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Fulvestrant and Capecitabine Oral Product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
13 sitesChina
Study dates
1 May 2018to 1 May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-75, including 18 and 75 years old), not suitable for surgical resection or radiation therapy for the purpose of cure;
  • Pathological examination confirmed ER and / or PR positive, HER-2 negative (Positive ER expression: immunohistochemistry >1% tumor cell staining; Positive PR expression: immunohistochemistry >1% tumor cell staining; HER-2 negative: immunohistochemistry is 0,1+, or FISH/CISH negative when immunohistochemistry is 2+);
  • Patients with advanced breast cancer who have no disease progression after a 4-8-course first-line chemotherapy regimen (the effect is evaluated as complete response/ partial response/ stable disease). Capecitabine monotherapy as first-line chemotherapy is allowed and the courses of treatment should be limited to 6.
  • WHO physical status 0-1 points, estimated lifetime at least 3 months;
  • Imaging examinations within 3 weeks before enrollment were required for assessing tumor lesions before maintenance treatment (Examination results from local Tertiary A hospital are available);
  • Previous treatment-related toxicity should be relieved to ≤ Grade 1 according to NCI CTCAE (version 4.03) before randomization (Except for hair loss and other toxicities that are not at risk to the patient's safety based on the investigator's judgment);
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  • The routine blood test was normal within 1 week before enrollment: WBC ≥3.0×10^9／L, b. ANC ≥1.5×10^9／L, c. PLT ≥100×10^9／L;
  • The liver and kidney function test was normal within 1 week before enrollment (Take the normal value of the laboratory of each research center as the standard): a. TBIL≤1.5× Upper Limit of Normal (ULN)b. ALT/AST≤2.5×ULN（Liver metastasis patients ≤5xULN） c. Serum Cr ≤1.5×ULN, or Ccr ≥60 ml/min;
  • Informed consent form signed before enrollment.

Who cannot join

  • Cannot be grouped if any of the following is true:
  • Newly developed central nervous system metastasis or symptom control of central nervous system is less than 4 weeks. (Patients with asymptomatic brian metastases which was stable more than 4 weeks by imaging assessment and do not need corticosteroid therapy are allowed to enrollment)
  • Diagnosis of any other malignant tumor within 3 years before randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ;
  • Endocrine therapy for advanced disease;
  • Pregnant or breast-feeding patients;
  • Patients with accompanying disease or situation that may interfere with the study, or any serious medical problems that may affect the safety of the subject (for example, uncontrolled heart disease or high blood pressure, active or uncontrolled infection, active hepatitis B virus infection);
  • Patients who were unable to tolerate capecitabine toxicity were first identified in first-line treatment;
  • Patients with recurrent metastatic disease within 2 years of adjuvant endocrine therapy (including 2 years);

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Herui Yao, PhD contact

+86 13500018020

yaoherui@mail.sysu.edu.cn

Wenjing Wu, PhD contact

+86 15902045077

wuwenjing@mail.sysu.edu.cn

13 sites in 1 country

China13 sites, 13 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Quchang Ouyang, PhD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Kun Wang, PhD

    Kun Wang, PhD

    Recruiting

  • Public Health Institute of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Li Ling, PhD

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Herui Yao, PhD, +86 13500018020, yaoherui@mail.sysu.edu.cn

    Herui Yao, PhD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Shusen Wang, PhD

    Shusen Wang, PhD

    Recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510000

    Mei Huang, MD

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Ying Lin, PhD

    Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

    Yongkui Lu, MD

    Recruiting

  • Shantou Central Hospital

    Shantou, Guangdong

    Zhiyong Wu, MD

    Recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong

    Caiwen Du, PhD

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Ruilian Xu, Master

    Not yet recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhangjiang, Guangdong

    Ying Zhang, MD

    Recruiting

  • Fifth Subsidiary Sun Yat-sen University Hospital

    Zhuhai, Guangdong

    Peijian Peng, PhD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Multi-center, Open-label, Phase III Trial of Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer (FAMILY)

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.

Read the detailed description

Metastatic breast cancer (MBC) is incurable. Although first-line endocrine therapy is preferred to hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) MBC, chemotherapy may be reserved as the initial treatment for patients with rapid clinical progression, life-threatening visceral metastases, and need for rapidly symptom control. Either prolonged chemotherapy or endocrine therapy may be used as maintenance after disease control. However, which maintenance strategy is superior in terms of delaying disease progression as well as maintaining quality of life (QOL) remains uncertain. This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in HR+/HER2- MBC.

Being tested
Fulvestrant, Capecitabine Oral Product
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Experimental group

    Fulvestrant 500mg Days 0, 14, 28, then every 28 days

  • Capecitabine Oral ProductDrug

    Also called Active Comparator control group

    Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Study groups in NCT04263298
Study groupRoleWhat they receive
Fulvestrant GroupExperimentalFulvestrant 500mg Days 0, 14, 28, then every 28 days
Receives: Drug: Fulvestrant
Capecitabine GroupActive comparatorCapecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off
Receives: Drug: Capecitabine Oral Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    From enrollment to progression or death (for any reason)

    Measured: Estimated 18 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    From enrollment to death (for any reason)

    Measured: Estimated 60 months

  2. Objective Response Rate (ORR)

    Ratio of CR and PR in all subjects

    Measured: Estimated 18 months

  3. Clinical Benefit Rate (CBR)

    Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

    Measured: Estimated 18 months

  4. Quality Of Life (QOL)

    All patients need to fill in the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer.

    Measured: Estimated up to 60 months

  5. Adverse Events and Serious Adverse Events

    Safety

    Measured: From informed consent through 28 days following treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start1 May 2018
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 May 2030 (estimated)

Resources

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
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04263298
Sponsor's protocol ID
SYS-C-201801-5010
Status last verified
Sep 2022
First submitted
4 Feb 2020
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu W, Yang Y, Chen H, Lu Y, Zeng Y, Zhao J, Du C, Lin Y, Peng P, Huang M, Zhang Y, Ouyang Q, Ding L, Cheng Z, Wen Y, Wu Z, Ye J, Ling L, Wang K, Lu Y, Zou G, Zhong J, Wang H, Lin D, Zeng D, Yao C, Chen Q, Zou L, Wang S, Yu Y, Yuan Z, Wang Y, Yao H. Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial. Signal Transduct Target Ther. 2026 May 22;11(1):191. doi: 10.1038/s41392-026-02720-6.

    PubMed 42168151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and Capecitabine Oral Product in people with Metastatic Breast Cancer, run by Herui Yao at 13 sites 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 8 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: looking for participants now, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Herui Yao, PhD (+86 13500018020, yaoherui@mail.sysu.edu.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: Estimated 18 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 NCT04263298, which also lists 1 linked publication.

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 30 Sep 2022.

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