TriangleDISEASE & TREATMENT SETTING
metastatic Breast Cancer
Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.
Exact scope
Treatment of Metastatic Breast Cancer
Broader topic: Breast Cancer
- Source population
- Not part of this definition
- Disease extent
- metastatic
- Treatment line
- Not part of this definition
- Stage
- Not part of this definition
- Resectability
- Not part of this definition
Biomarkers, prior therapy and derivation
- molecular
- prior therapy
- derivation status
- source-attested
- derivation note
- Scoped from an NCI treatment-summary heading. NCI PDQ is an evidence summary, not a practice guideline, and only the dimensions the heading states are part of this definition.
- source wording
- Treatment of Metastatic Breast Cancer
Study evidence for this setting
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory t
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens o
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
Indication-specific source history
1998-04-30 · Xeloda (capecitabine) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- fda-d28c492fc3a1807f
- event date
- 1998-04-30
- event kind
- accelerated-approval
- drug or regimen
- Xeloda (capecitabine)
- source indication text
- Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-202c581a375484cc6391
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2001-09-07 · Xeloda (capecitabine) · traditional approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- fda-b705cd2385eb8b56
- event date
- 2001-09-07
- event kind
- traditional-approval
- drug or regimen
- Xeloda (capecitabine)
- source indication text
- Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-202c581a375484cc6391
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2010-01-29 · Tykerb (lapatinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- fda-453bf4887c8a82cd
- event date
- 2010-01-29
- event kind
- accelerated-approval
- drug or regimen
- Tykerb (lapatinib)
- source indication text
- In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-82cf35181d5af795f260
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2018-12-06 · Tykerb (lapatinib) · traditional approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- fda-c4e6cfae42965d72
- event date
- 2018-12-06
- event kind
- traditional-approval
- drug or regimen
- Tykerb (lapatinib)
- source indication text
- In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-82cf35181d5af795f260
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-09-25 · imlunestrant · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- notice-0341406950d2e2c1
- event date
- 2025-09-25
- event kind
- approval-notification
- drug or regimen
- imlunestrant
- source indication text
- FDA approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor -positive, human epidermal growth factor 2 -negative, estrogen receptor-1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-e6329c4a9f1a5704
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-05-01 · vepdegestrant · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- notice-b283e128dcf24c90
- event date
- 2026-05-01
- event kind
- approval-notification
- drug or regimen
- vepdegestrant
- source indication text
- FDA approved vepdegestrant, a heterobifunctional protein degrader, for adults with estrogen receptor -positive, human epidermal growth factor receptor 2 -negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-139bc569cd69b40c
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-06-24 · palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- notice-aeeccf96999ad841
- event date
- 2026-06-24
- event kind
- approval-notification
- drug or regimen
- palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy
- source indication text
- FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-679b968656ef28cf
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-07-14 · gedatolisib with fulvestrant, with or without palbociclib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- notice-a811e7ad63acc0cc
- event date
- 2026-07-14
- event kind
- approval-notification
- drug or regimen
- gedatolisib with fulvestrant, with or without palbociclib
- source indication text
- FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-cfcc707359fdc22f
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-09-04 · Etcamah (camizestrant) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- fda-e2bb1179d3531239
- event date
- 2026-09-04
- event kind
- accelerated-approval
- drug or regimen
- Etcamah (camizestrant)
- source indication text
- In combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-086f7c231b1cbc70103f
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-09-04 · camizestrant with a CDK4/6 inhibitor · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-metastatic-f5df9fba
- event id
- notice-ec0e45c844fdd263
- event date
- 2026-09-04
- event kind
- approval-notification
- drug or regimen
- camizestrant with a CDK4/6 inhibitor
- source indication text
- FDA approved camizestrant, an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
- match phrase
- metastatic breast cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-29ff88a8fe51d0cc
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Source relationships and population-mapping limitations
- bindings
- mappings
Download this complete draft source relationship record →
Preserved source evidence · Not medical advice