TABLE 2.

Some recently completed and ongoing clinical trials on breast cancer treatment targeting prolactin and its receptors

Entry	Drug	NCT Number	Trial title	Status	Conditions	Interventions	Study type	Study phase	Study design	Enrollment	Age	Sex	Sponsor/collaborators
1	LFA102	NCT01338831	Phase I study of LFA102 in patients with prolactin receptor‐positive castration‐resistant prostate cancer or prolactin receptor‐positive metastatic breast cancer	Completed	Castration‐resistant prostate cancer Metastatic breast cancer Uterine leiomyoma	Drug: LFA102	Interventional	Phase 1	Allocation: non‐randomized Intervention model: single group assignment Masking: none (open label) Primary purpose: treatment	73	18 years and older (adult, older adult)	All	Novartis Pharmaceuticals Novartis
2	cabergoline	NCT01730729	Cabergoline in metastatic breast cancer	Completed	Recurrent breast cancer Stage IV breast cancer	Drug: cabergoline	Interventional	Early phase 1	Intervention model: single group assignment Masking: none (open label) Primary purpose: treatment	20	18 years and older (adult, older adult)	Female	Northwestern University Lynn Sage Foundation
3	–	NCT00842465	Prolactin Receptor and Breast Diseases	Completed	Benign breast disease Breast cancer	Biological: blood collection for hormonal status analysis Procedure: breast Biopsy or surgery Genetic: blood collection Other: ultrasonography (pelvis and breast), bone mineral density	Observational	–	Time perspective: cross‐ sectional	735	10 years and older (child, adult, older adult)	Female	Assistance Publique ‐ Hôpitaux de Paris Institut Pasteur
4	Nimesulide Simvastatin Placebo	NCT01500577	A prevention trial in subjects at high risk for breast cancer	Completed	Breast cancer	Drug: nimesulide Drug: simvastatin Other: placebo	Interventional	Phase 2	Allocation: randomized Intervention model: parallel assignment Masking: double (participant, investigator) Primary purpose: prevention	150	18 years to 65 years (adult, older adult)	Female	European Institute of Oncology
5	LFA102	NCT01610050	A phase I study of LFA102 in Japanese patients	Completed	Castration‐resistant prostate cancer, advanced breast cancer	• Drug: LFA102	Interventional	Phase 1	Allocation: non‐ randomized Intervention model: single group assignment Masking: none (open label) Primary purpose: treatment	14	18 years and older (adult, older adult)	All	Novartis Pharmaceuticals Novartis
6	–	NCT00516698	Changes in breast density and blood hormone levels in postmenopausal women receiving anastrozole or exemestane for breast cancer	Completed	Breast cancer	Genetic: polymorphism analysis Other: high performance liquid chromatography Other: laboratory biomarker analysis Procedure: radiomammography	Observational	–	Observational model: case‐only Time perspective: prospective	140	18 Years and older (Adult, Older Adult)	Female	Alliance for clinical trials in oncology National Cancer Institute (NCI)
7	‐	NCT00973557	The effect of monoclonal vascular endothelial growth factor (VEGF) antibody (bevacizumab) on pituitary function	Completed	Colorectal cancer Lung cancer Breast cancer Glioblastoma	–	Observational	–	Observational model: cohort Time perspective: cross‐ sectional	6	18 years and older (adult, older adult)	All	Cedars‐Sinai Medical Center
8	–	NCT00860886	Premenopausal hormone concentrations in a population of women at very low risk of breast cancer	Completed	Menopause Normal physiology	–	Observational	–	Observational model: case‐control Time perspective: cross‐ sectional	433	25 years to 44 years (adult)	Female	National Cancer Institute (NCI) National Institutes of Health Clinical Center (CC)
9	Drug: GDC‐9545 Drug: Palbociclib Drug: LHRH agonist	NCT03332797	A study of GDC‐9545 alone or in combination with palbociclib and/or luteinizing hormone‐ releasing hormone (LHRH) agonist in locally advanced or metastatic estrogen receptor‐positive breast cancer	Recruiting	• Breast cancer	Drug: GDC‐9545 Drug: palbociclib Drug: LHRH agonist	Interventional	Phase 1	Allocation: non‐ randomized Intervention model: sequential assignment Masking: none (open label) Primary purpose: treatment	220	18 years and older (adult, older adult)	Female	Genentech, Inc.
10	Exemestane	NCT00073073	Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer	Completed	• Breast Neoplasms	Drug: exemestane Dietary supplement: Calcium carbonate Dietary supplement: vitamin D	Interventional	Phase 2	Intervention model: single group assignment Masking: none (open label) Primary purpose: prevention	46	Child, adult, older adult	Female	Georgetown University National Cancer Institute (NCI)
11	Drug: tamoxifen Drug: tamoxifen and GnRH analogue Drug: exemestane and GnRH analogue	NCT01638247	Tamoxifen +/− GnRH analogue vs aromatase inhibitor + GnRH analogue in male breast cancer patients	Completed	Male breast cancer	Drug: tamoxifen Drug: tamoxifen and GnRH analogue Drug: exemestane and GnRH analogue	Interventional	Phase 3	Allocation: randomized Intervention model: parallel assignment Masking: none (open label) Primary purpose: treatment	56	18 years to 85 years (adult, older adult)	Male	German Breast Group Pfizer
12	Drug: intravenous morphine sulphate Drug: intravenous tramadol HCL Drug: intravenous ketorolac tromethamine	NCT02449954	Effect of morphine, tramadol, and ketorolac on postoperative stress and immune responses	Unknown status	Breast cancer	Drug: intravenous morphine sulphate Drug: intravenous tramadol HCL Drug: intravenous ketorolac tromethamine	Interventional	Phase 2 Phase 3	Allocation: randomized Intervention model: crossover assignment Masking: double (investigator, outcomes assessor) Primary purpose: diagnostic	60	20 years to 60 years (Adult)	Female	Assiut University
13	Drug: dexmedetomidine injection [Precedex] Drug: bupivacaine	NCT03063073	Efficacy and safety of dexmedetomidine added to modified pectoral's block	Unknown status	Breast cancer female	Drug: dexmedetomidine injection [Precedex] Drug: bupivacaine	Interventional	Phase 3	Allocation: randomized Intervention model: parallel assignment Masking: triple (participant, care provider, outcomes assessor) Primary purpose: prevention	60	18 years to 60 years (Adult)	Female	South Egypt Cancer Institute
14		NCT02197000	A nutritional intervention to decrease breast density among female BRCA (BReast CAncer susceptibility gene) carriers	Unknown status	BRCA1 gene mutation BRCA2 gene mutation	• Dietary supplement: DIM‐ Avail 100 mg	Interventional	–	Intervention model: single group assignment Masking: none (open label) Primary purpose: prevention	36	18 years to 70 years (adult, older adult)	Female	Rabin medical center
15	ABBV‐176	NCT03145909	A study evaluating the safety, pharmacokinetics and anti‐tumor activity of ABBV‐176 in subjects with advanced solid tumors likely to express prolactin receptor (PRLR)	Terminated	Advanced solid tumors cancer	Drug: ABBV‐176	Interventional	Phase 1	Allocation: non‐ randomized Intervention model: parallel assignment Masking: none (open label) Primary purpose: treatment	19	18 years and older (adult, older adult)	All	AbbVie
16	–	NCT00006368	Yttrium Y 90 SMT 487 in treating patients with refractory or recurrent cancer	Completed	Brain and central nervous system Tumors Breast cancer Gastrointestinal carcinoid tumor Islet cell tumor Lung cancer Lymphoma Melanoma (Skin) Neoplastic Syndrome	Radiation: yttrium Y 90‐edotreotide	Interventional	Phase 1	Primary purpose: treatment	60	18 years and older (Adult, Older Adult)	All	Novartis Pharmaceuticals Novartis
17	Telapristone acetate	NCT02314156	Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy	Active, not recruiting	BRCA1 mutation carrier BRCA2 mutation carrier Ductal breast carcinoma in situ Lobular breast carcinoma in situ Stage 0 breast cancer Stage IA breast cancer Stage IB breast cancer Stage IIA breast cancer Stage IIB breast cancer	Drug: telapristone acetate Other: placebo Other: laboratory biomarker analysis Other: questionnaire administration	Interventional	Phase 2	Allocation: randomized Intervention model: parallel assignment Masking: single (participant) Primary purpose: prevention	67	18 years and older (adult, older adult)	Female	Northwestern University National Cancer Institute (NCI)