Clinical trial · Interventional
Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer
Bevacizumab Plus Paclitaxel Optimization Study With Interventional Maintenance Endocrine Therapy in Advanced or Metastatic ER-positive HER2-negative Breast Cancer -BOOSTER Trial, a Multicenter Randomized Phase II Study-
NCT01989780CI-TRIAL-00060104BOOSTERcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| leuprorelin | Drug | Leuprolide | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- weekly paclitaxel + bevacizumab
- interventionNames
- Drug: Paclitaxel
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- endocrine therapy\* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy (\*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
- interventionNames
- Drug: Paclitaxel
- Drug: Bevacizumab
- Drug: Letrozole
- Drug: Anastrozole
- Drug: Exemestane
- Drug: Fulvestrant
- Drug: Goserelin
- Drug: leuprorelin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the breast
2. Female aged 20-75 years old at getting informed consent
3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)
4. Documented estrogen receptor (ER) positive (\>=1% by IHC)
5. Inoperative locally advanced or metastatic breast cancer at enrolment
6. Performance status (ECOG): 0-1 at enrolment
7. Life expectancy of at least 3 months from enrolment
8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)
9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of \>= 12 months
10. Patients with measurable lesion regarding with Response Evaluation Criteria in Solid Tumors(RECIST) criteria or who have evaluable lesion
11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT
12. No influence on protocol treatment is considered in case prior therapy or examination.
13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination.
* Absolute neutrophil count \>= 1500 /mm3 or white blood cell(WBC) count \>= 3000 /mm3
* Platelets \>=10 x 10000 /mm3
* Hb \>= 9 g/dL
* Total bilirubin \<= 1.5 mg/dL
* aspartate aminotransferase(AST) and alanine aminotransferase(ALT) \<= 100 international unit(IU)/L
* Serum creatinine \<= 1.5 mg/dL
* Urine dipstick for proteinuria \<= 1+
14. Written informed consent signed by patients before completing any treatment related procedure
Exclusion Criteria:
1. Prior therapy with bevacizumab
2. Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.
3. Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.
4. Known hypersensitivity to bevacizumab or paclitaxel
5. History of hemoptysis (\>= 2.5mL of bright red blood per episord).
6. Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride
7. Patients with CNS metastases (except for not symptomatic)
8. Persistent Grade \>= 2 sensory neuropathy at enrollment
9. Grade 3 \>= hypertension (\>= 2 use of antihypertensive drug)
10. Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.
11. Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.
12. History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment
13. Cases that the investigator judged as inappropriate as the subject of this clinical studyReferences
Publications (1)
- DERIVEDSaji S, Taira N, Kitada M, Takano T, Takada M, Ohtake T, Toyama T, Kikawa Y, Hasegawa Y, Fujisawa T, Kashiwaba M, Ishida T, Nakamura R, Yamamoto Y, Toh U, Iwata H, Masuda N, Morita S, Ohno S, Toi M. Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2022 May;23(5):636-649. doi: 10.1016/S1470-2045(22)00196-6. Epub 2022 Apr 8. PMID 35405087