8.4 – Hormone responsive malignancy

Related guidance:

Early and locally advanced breast cancer: diagnosis and management NICE guideline (NG101 July 2018, updated June 2023)

Adjuvant endocrine therapy for invasive breast cancer

• Offer tamoxifen as the initial adjuvant endocrine therapy for men and premenopausal women with ER (oestrogen receptor) positive invasive breast cancer.
• Offer an aromatase inhibitor as the initial adjuvant endocrine therapy for postmenopausal women with ER-positive invasive breast cancer who are at medium or high risk of disease recurrence. Offer tamoxifen to women who are at low risk of disease recurrence, or if aromatase inhibitors are not tolerated or are contraindicated. Risk can be estimated using a range of standardised tools and clinical expertise.

Extended endocrine therapy

• Offer extended therapy (total duration of endocrine therapy of more than 5 years) with an aromatase inhibitor for postmenopausal women with ER-positive invasive breast cancer who are at medium or high risk of disease recurrence and who have been taking tamoxifen for 2 to 5 years. Medium or high risk may include people who have lymph node-positive breast cancer, with tumours that are T2 or greater and higher grade.
• Consider extended therapy (total duration of endocrine therapy of more than 5 years) with an aromatase inhibitor for postmenopausal women with ER-positive invasive breast cancer who are at low risk of disease recurrence and who have been taking tamoxifen for 2 to 5 years. Low risk may include people with lymph node-negative breast cancer, with smaller or lower-grade tumours.
• Consider extending the duration of tamoxifen therapy for longer than 5 years for both premenopausal and postmenopausal women with ER-positive invasive breast cancer.
• Discuss the benefits and risks of extended endocrine therapy with women.

Women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby.

Bone health

• Offer a baseline dual-energy X-ray absorptiometry (DEXA) scan to assess bone mineral density (BMD) in women with invasive breast cancer who are not receiving bisphosphonates as adjuvant therapy and who:
  • are starting adjuvant aromatase inhibitor treatment or
  • have treatment-induced menopause or
  • are starting ovarian ablation/suppression therapy.
• Do not offer a DEXA scan to women with invasive breast cancer who are receiving tamoxifen alone, regardless of their pretreatment menopausal status.
• Offer bisphosphonates to women identified by algorithms 1 and 2 (see below) in Guidance for the management of breast cancer treatment-induced bone loss: a consensus position statement from a UK expert group (July 2008)

 

Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer Clinical guideline (CG164 June 2013, updated November 2023)

• Patient decision aid on taking tamoxifen to reduce the chance of developing breast cancer for premenopausal women at high risk
• Patient decision aid on taking tamoxifen to reduce the chance of developing breast cancer for premenopausal women at moderately increased risk
• Patient decision aid on taking a medicine to reduce the chance of developing breast cancer for postmenopausal women at high risk
• Patient decision aid on taking a medicine to reduce the chance of developing breast cancer for postmenopausal women at moderately increased risk

For Raloxifene see NHS Somerset Formulary Female sex hormone responsive conditions

Recommendations about chemoprevention for women at high risk of breast cancer

• Offer tamoxifen for 5 years to premenopausal women at high risk of breast cancer unless they have a past history or may be at increased risk of thromboembolic disease or endometrial cancer.
• Offer anastrozole for 5 years to postmenopausal women at high risk of breast cancer unless they have severe osteoporosis. Women with or at risk of osteoporosis should have their bone mineral density assessed when starting treatment and then at regular intervals. Treatment or prophylaxis for osteoporosis should be started when needed and carefully monitored.
• For postmenopausal women at high risk of breast cancer who have severe osteoporosis or do not wish to take anastrozole:
  • offer tamoxifen for 5 years if they have no history or increased risk of thromboembolic disease or endometrial cancer, or
  • consider raloxifene for 5 years for women with a uterus if they have no history or increased risk of thromboembolic disease and do not wish to take tamoxifen (Off-label).
• Do not offer chemoprevention to women who were at high risk of breast cancer but have had bilateral risk-reducing mastectomy.

Recommendations about chemoprevention for women at moderate risk of breast cancer

• Consider tamoxifen for 5 years for premenopausal women at moderate risk of breast cancer, unless they have a past history or may be at increased risk of thromboembolic disease or endometrial cancer.
• Consider anastrozole for 5 years for postmenopausal women at moderate risk of breast cancer unless they have severe osteoporosis. Women with or at risk of osteoporosis should have their bone mineral density assessed when starting treatment and then at regular intervals. Treatment or prophylaxis for osteoporosis should be started when needed and carefully monitored.
• For postmenopausal women at moderate risk of breast cancer who have severe osteoporosis or do not wish to take anastrozole:
  • consider tamoxifen for 5 years if they have no history or increased risk of thromboembolic disease or endometrial cancer, or
  • consider raloxifene for 5 years for women with a uterus if they have no history or increased risk of thromboembolic disease and do not wish to take tamoxifen (Off-label).

Recommendations for all women taking drugs for chemoprevention

• Do not continue chemoprevention beyond 5 years in women with no personal history of breast cancer.
• Inform women that they should stop tamoxifen at least:
  • 2 months before trying to conceive
  • 6 weeks before elective surgery.

Advanced breast cancer: diagnosis and treatment Clinical guideline (CG81 February 2009, updated August 2017)

Endocrine therapy

• Offer an aromatase inhibitor (either non-steroidal or steroidal) to:
  • postmenopausal women with ER-positive breast cancer and no prior history of endocrine therapy
  • postmenopausal women with ER-positive breast cancer previously treated with tamoxifen.
• Offer tamoxifen and ovarian suppression as first-line treatment to premenopausal and perimenopausal women with ER-positive advanced breast cancer not previously treated with tamoxifen.
• Offer ovarian suppression to premenopausal and perimenopausal women who have previously been treated with tamoxifen and then experience disease progression.
• Offer tamoxifen as first-line treatment to men with ER-positive advanced breast cancer.

Therapeutic Area	Formulary Choices	Cost for 28 (unless otherwise stated)	Rationale for decision / comments
Hormone antagonists and related agents, aromatase inhibitors
	Anastrozole	1mg tablet: £1.09	NHS Somerset classify as Amber for adjuvant endocrine treatment of postmenopausal people with advanced oestrogen receptor positive breast cancer and as a preventative treatment for post-menopausal women at moderate or high risk of breast cancer as per Traffic light guidance. Take one tablet daily.
	Letrozole	2.5mg tablet: £0.95 (14), £1.90	NHS Somerset classify as Amber for adjuvant endocrine treatment of postmenopausal people with advanced oestrogen receptor positive breast cancer as per Traffic light guidance. Take one tablet daily.
	Consider bone protection with ALL Aromatase inhibitors as high risk of fractures. See Bone metabolism disorders
Antineoplastic drugs, anti-oestrogens
	Tamoxifen	10mg tablet: £38.01 (30)	For initial adjuvant endocrine therapy for men and premenopausal women with oestrogen receptor positive invasive breast cancer. For the primary prevention of breast cancer in women at moderate or high risk. The recommended daily dose is normally 20mg daily or as per specialist. Women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby.
		20mg tablet: £2.53 (30)
		40mg tablets: £95.16 (30)
Prostate cancer & Gonadorelin analogues
	Triptorelin acetate as Decapeptyl SR®	3mg powder and solvent for suspension for injection vial: £69.00 (1)	One intramuscular injection should be administered every 4 weeks (28 days). Triptorelin acetate is classified by NHS Somerset as Amber as per Traffic light guidance and is first line for use in prostatic cancer. Triptorelin acetate is classified by NHS Somerset as Amber as per Traffic light guidance for the treatment of endometriosis or uterine fibroids (as per SPF March 2010).
	Triptorelin pamoate as Decapeptyl SR®	11.25mg powder and solvent for suspension for injection vial: £207.00 (1)	One intramuscular injection administered every 3 months.
		22.5mg powder and solvent for suspension for injection vial: £414.00 (1)	One intramuscular injection administered every 6 months (24 weeks). For use in prostatic cancer only. Triptorelin 22.5mg prescribed for stable patients for long term use has significantly less carbon footprint compared with the 3 and 11.25mg, reducing appointment/nurse time, prescription issues and waste.
	Leuprorelin acetate as Prostap® SR DCS	3.75mg powder and solvent for suspension for injection pre-filled syringe: £75.24	One subcutaneous or intramuscular injection administered every month. Leuprorelin acetate is classified by NHS Somerset as Amber as per Traffic light guidance and is second line for use in prostatic cancer.
	Leuprorelin acetate as Prostap® 3DS	11.25mg powder and solvent for suspension for injection pre-filled syringe: £225.72	One subcutaneous injection administered every 3 months. Administered every 13 weeks rather that 12 making it more cost effective than goserelin.
	Leuprorelin acetate as Staladex®	11.25mg implant pre-filled syringe: £208.79 (1)	One implant injected subcutaneously every 3 months.
	Goserelin acetate as Zoladex®	3.6mg implant pre-filled syringe: £65.00 (1)	One implant injected subcutaneously every 28 days. Goserelin is classified as Amber as per traffic light guidance as third line option for use in prostate cancer. Goserelin is classified as Amber as per traffic light guidance for the treatment of endometriosis and uterine fibroids. The 3.6mg implant is classified as Amber as per traffic light guidance for the treatment of advanced breast cancer in pre and perimenopausal women suitable for hormonal manipulation and as an alternative to chemotherapy in the standard of care for pre/perimenopausal women with oestrogen receptor positive early breast cancer.
	Goserelin acetate as Zoladex LA®	10.8mg implant pre-filled syringe: £235.00 (1)	One implant injected subcutaneously every 12 weeks.