Breast CancerPhase 3AMBITIONNCT04732598
A Phase III Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer
A Phase 3 study testing Paclitaxel + bevacizumab therapy and Paclitaxel + bevacizumab + atezolizumab in people with Breast Cancer, run by Japanese Foundation for Cancer Research at 1 site in Japan.
Trial summary
JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel + bevacizumab therapy and Paclitaxel + bevacizumab + atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jan 2021to 13 Mar 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed as breast cancer (invasive cancer).
- Histologically diagnosed as hormone receptor positive (at least one of ER and PgR is positive) and HER2 negative. However, if there are multiple specimens, the histological results of the most recent specimen that meets the eligibility criteria 1. and 2. should be used.
- Diagnosed with advanced recurrent breast cancer (either unresectable locally advanced breast cancer, recurrent breast cancer, or Stage IV breast cancer).
- Age 20 years or older on the date of registration. Either male or female are acceptable.
- ECOG performance status (PS) of 0-2.
- Patients must have measurable lesions.
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- Hormone refractory[*a] or life-threatening metastases [*b].
- Hormone refractory: Recurrence within 2 years after the start of postoperative endocrine therapy, or progression within 6 months of endocrine therapy for advanced recurrent breast cancer.
- Life-threatening metastases: Symptomatic metastases that require symptomatic relief through urgent tumor shrinkage. Examples include multiple liver metastases, lung metastases, carcinomatous pleurisy, and carcinomatous lymphangitis.
- PD-L1 status has been confirmed by a central measurement institute.
- No active brain metastases that require treatment.
- No history of prior chemotherapy treatment for advanced or recurrent breast cancer. However, in case that a history of preoperative/postoperative chemotherapy including paclitaxel or docetaxel, it is acceptable if at least 6 months have passed since the last dose.
- The most recent laboratory test within 14 days prior to enrollment (the same day of the week two weeks prior to the date of enrollment is acceptable) must meet all of the following
- Neutrophil count ≥1,500/mm^3
- Hemoglobin ≥ 9.0 g/dL (No blood transfusion within 14 days prior to the date of blood collection for the test used for registration)
- Platelet count ≥10×104/mm^3
- Total bilirubin ≤ 1.5 mg/dL
- AST ≤ 100 IU/L (≤ 150 IU/L if liver metastasis is present)
- ALT ≤ 100 IU/L (≤ 150 IU/L in case of liver metastasis)
- Serum creatinine ≤1.2 mg/dL
- PT-INR ≤ 1.5, but PT-INR ≤ 3.0 if the patient is taking anticoagulants such as warfarin prophylactically.
- Urine protein (test paper method) of 1+ or less
- For women of childbearing potential [*a], consent for contraception from the time of obtaining consent until at least 6 months after completion of the protocol treatment. For lactating patients, the patient agrees not to breastfeed from the start of protocol treatment until at least 6 months after the end of protocol treatment. For men, they agree to use contraception from the start of protocol treatment until at least 6 months after the end of protocol treatment [*b].
- Women of childbearing potential: Women who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral oophorectomy), and have not undergone menopause. Menopause is defined as the absence of menstruation for more than 12 months without another medical reason such as drug administration.
- Examples of contraceptive methods: condoms, pessaries, oral contraceptives, use of intrauterine devices, etc.
- The patient's written consent to participate in the study has been obtained.
Who cannot join
- Active multiple cancer. However, the following are excluded: ①Completely resected cancers: basal cell carcinoma, Stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, superficial bladder cancer, ② gastrointestinal tract cancer that has been curatively resected by ESD or EMR, and ③ other cancers that have not recurred for more than 5 years.
- Infectious diseases that require systemic treatment.
- Complicated active gastrointestinal ulcer.
- Patients must have poorly controlled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) despite the use of two or more antihypertensive agents.
- Patients must have symptomatic congestive heart failure, unstable angina, or arrhythmia requiring treatment at the time of enrollment.
- History of myocardial infarction within 1 year prior to enrollment.
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- Major surgery or incisional biopsy or significant trauma within 28 days prior to enrollment; placement of a CV port is not considered major surgery.
- Patients with deep vein thrombosis or pulmonary embolism at the time of enrollment, or a history of such within 1 year prior to enrollment.
- Use of anticoagulants (except aspirin of 324 mg/day or less) within 10 days prior to enrollment.
- Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (bronchiolitis obliterans, etc.), drug-induced pneumonitis, or idiopathic pneumonitis. However, patients with a history of drug-induced pneumonitis who are asymptomatic at the time of enrollment can be enrolled if they undergo regular chest X-ray examinations and careful follow-up including auscultation and medical examination.
- Findings of active pneumocystitis on chest CT. However, a history of localized radiation pneumonitis (fibrosis) in the irradiation field is inclusible.
- Patients have been treated with investigational atezolizumab, or other immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody drugs), or immunostimulants (e.g., interferon, interleukin-2).
- Active autoimmune disease, immunodeficiency, or history thereof (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, etc.). However, the following are inclusible. Patients with autoimmune hypothyroidism who are using a stable dose of thyroid hormone preparations. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo vulgaris whose symptoms are limited to the skin, and whose rash accounts for less than 10% of the body surface area and is well controlled by topical application of low potency corticosteroids alone. No acute exacerbation of the underlying disease requiring solaren long-wavelength ultraviolet therapy, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high potency or oral corticosteroids within the past 12 months.
- Patients who have received a live attenuated vaccine within 4 weeks prior to enrollment or are expected to require a live attenuated vaccine within 5 months of completion of protocol treatment.
- Patients have not recovered from clinically significant toxicity caused by previous therapy, except for alopecia and Grade 1 peripheral neuropathy.
- Hypersensitivity or contraindication to any component of the therapeutic agent, including macrogol glycerol ricinoleate (Cremophor®), an additive to paclitaxel.
- Positive for HIV antibodies, HBs antigen, or HCV antibodies (however, if HCV antibodies are positive but HCV-RNA is not detected, it is not excluded).
- Negative for HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA quantification.
- Women who are pregnant, lactating, or may be pregnant.
- Patients with psychosis or psychiatric symptoms that interfere with daily life and are judged to be difficult to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer
JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel + bevacizumab therapy, Paclitaxel + bevacizumab + atezolizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + bevacizumab therapyDrug
The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met.
[Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV
Paclitaxel + bevacizumab + atezolizumabDrug
The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met.
[Atezolizumab] 840 mg/body, day 1,15, IV [Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Drug: Paclitaxel + bevacizumab therapy |
| Arm B | Experimental | Not described Receives: Drug: Paclitaxel + bevacizumab + atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (investigator-assessed)
Measured: Up to 2years after last patient enrolled
Secondary outcomes (15)
Progression-free survival (blinded independent central review)
Measured: Up to 2years after last patient enrolled
Overall survival
Measured: Up to 2years after last patient enrolled
Response rate (investigator-assessed)
Measured: Up to 2years after last patient enrolled
Duration of response (investigator-assessed)
Measured: Up to 2years after last patient enrolled
Response rate (blinded independent central review)
Measured: Up to 2years after last patient enrolled
Duration of response (blinded independent central review)
Measured: Up to 2years after last patient enrolled
Incidence of adverse events
Measured: Up to 2years after last patient enrolled
Incidence of serious adverse events
Measured: Up to 2years after last patient enrolled
Incidence of immune-related adverse events
Measured: Up to 2years after last patient enrolled
Progression-free survival in PD-L1 positive subpopulation (investigator-assessed)
Measured: Up to 2years after last patient enrolled
PD- L1-positive subpopulation
Measured: Up to 2years after last patient enrolled
Progression-free survival in the PD-L1-positive subpopulation (investigator-assessed)
Measured: Up to 2years after last patient enrolled
Overall survival in the PD-L1-positive subpopulation
Measured: Up to 2years after last patient enrolled
Response rate in the PD-L1-positive subpopulation (investigator-assessed)
Measured: Up to 2years after last patient enrolled
Response rate in the PD-L1-positive subpopulation (blinded independent central review)
Measured: Up to 2years after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start21 Jan 2021
- Primary completion12 Sep 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japanese Foundation for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Principal investigator, Fumikata Hara, Aichi Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732598
- Sponsor's protocol ID
- JCOG1919E
- Acronym
- AMBITION
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04732598
- Acronym / sponsor ID
- AMBITION / JCOG1919E
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Japanese Foundation for Cancer ResearchUniversity, hospital or other
- Collaborators
- Chugai Pharmaceutical
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 1 Feb 2021 (actual)
- 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.
JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Paclitaxel + bevacizumab therapy |
| Arm B | Experimental | Drug: Paclitaxel + bevacizumab + atezolizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically diagnosed as breast cancer (invasive cancer).
- Histologically diagnosed as hormone receptor positive (at least one of ER and PgR is positive) and HER2 negative. However, if there are multiple specimens, the histological results of the most recent specimen that meets the eligibility criteria 1. and 2. should be used.
- Diagnosed with advanced recurrent breast cancer (either unresectable locally advanced breast cancer, recurrent breast cancer, or Stage IV breast cancer).
- Age 20 years or older on the date of registration. Either male or female are acceptable.
- ECOG performance status (PS) of 0-2.
Key exclusion criteria (20 listed)
- Active multiple cancer. However, the following are excluded: ①Completely resected cancers: basal cell carcinoma, Stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, superficial bladder cancer, ② gastrointestinal tract cancer that has been curatively resected by ESD or EMR, and ③ other cancers that have not recurred for more than 5 years.
- Infectious diseases that require systemic treatment.
- Complicated active gastrointestinal ulcer.
- Patients must have poorly controlled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) despite the use of two or more antihypertensive agents.
- Patients must have symptomatic congestive heart failure, unstable angina, or arrhythmia requiring treatment at the time of enrollment.
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 |
|---|---|---|
| Paclitaxel + bevacizumab therapyThe following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met. [Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV | Drug | Arm A |
| Paclitaxel + bevacizumab + atezolizumabThe following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met. [Atezolizumab] 840 mg/body, day 1,15, IV [Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV | Drug | Arm B |
Primary outcome
Progression-free Survival (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
15 secondary outcomes
Progression-free survival (blinded independent central review)
Time frame: Up to 2years after last patient enrolled
Overall survival
Time frame: Up to 2years after last patient enrolled
Response rate (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
Duration of response (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
Response rate (blinded independent central review)
Time frame: Up to 2years after last patient enrolled
Duration of response (blinded independent central review)
Time frame: Up to 2years after last patient enrolled
Incidence of adverse events
Time frame: Up to 2years after last patient enrolled
Incidence of serious adverse events
Time frame: Up to 2years after last patient enrolled
Incidence of immune-related adverse events
Time frame: Up to 2years after last patient enrolled
Progression-free survival in PD-L1 positive subpopulation (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
PD- L1-positive subpopulation
Time frame: Up to 2years after last patient enrolled
Progression-free survival in the PD-L1-positive subpopulation (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
Overall survival in the PD-L1-positive subpopulation
Time frame: Up to 2years after last patient enrolled
Response rate in the PD-L1-positive subpopulation (investigator-assessed)
Time frame: Up to 2years after last patient enrolled
Response rate in the PD-L1-positive subpopulation (blinded independent central review)
Time frame: Up to 2years after last patient enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paclitaxel + bevacizumab therapy and Paclitaxel + bevacizumab + atezolizumab in people with Breast Cancer, run by Japanese Foundation for Cancer Research at 1 site in Japan.
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 26 inclusion and 20 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: finished, as of the sponsor's last update on 21 Apr 2026. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (investigator-assessed) (time frame: Up to 2years after last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.